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Legal Head of Compliance at Gauntlet

Builds and operates a comprehensive compliance program across financial crime, regulatory, privacy, and employment domains, establishing policies, processes, and monitoring while partnering with cross-functional teams.

Lead Posted about 21 hours ago RemoteFirstJobs Product
What this role involves

The role

Gauntlet is hiring its first dedicated Head of Compliance. Compliance responsibilities currently sit across Legal and the wider business. This role brings that work together, identifies the gaps, and establishes a clear, practical program that scales with the company.

Reporting to the General Counsel, you will set the direction but also own the execution: writing the policies, building the processes, implementing the tooling, and running the monitoring to make sure the program works in practice.

Gauntlet recently completed its Series C and as the business grows we need a compliance program that keeps pace without creating unnecessary friction. The scope is broad - financial crime, securities regulation, privacy, marketing, employment, anti-corruption, regulatory registrations, and other areas that emerge as the business develops.

This is a hands-on senior role with meaningful ownership, direct access to company leadership, and the chance to build a program suited to an onchain financial business rather than inherit one designed for a different kind of company.

About Gauntlet

Gauntlet builds the financial systems of the future. While much of on-chain finance is focused on point solutions, we operate across the entire stack to offer best-in-class vault products. Today, we serve over $1.6B in client TVL across some of the largest fintechs/neobanks, protocols, exchanges, and capital allocators in crypto, and, increasingly, traditional asset management. Our team brings together traditional finance and crypto-native expertise to deliver durable, sophisticated products for institutional clients moving on-chain

What you’ll do;

  • Build and run Gauntlet’s compliance program, including its priorities, governance, controls, and operating cadence.
  • Draft, update, and implement policies and procedures across the business, and establish a practical compliance testing and monitoring program.
  • Create reporting, escalation, and governance processes that give leadership a clear view of compliance risks and issues.
  • Support upcoming registrations, help prepare the business for the regulatory requirements that follow, and coordinate regulatory examinations, audits, and related information requests.
  • Partner with Legal, Product, Engineering, Finance, People, and commercial teams to incorporate compliance requirements into their day-to-day work, and review and improve company-wide compliance training.
  • Advise the business across financial crime, privacy, marketing, securities, anti-corruption, employment, and other relevant areas.
  • Use AI and automation to make monitoring, reporting, policy management, and other compliance workflows more efficient.
  • Keep the program current as Gauntlet’s products, clients, and regulatory obligations evolve.

What success looks like;

First 30 days. Map the compliance work already happening across Legal and the wider business. Meet stakeholders across Product, Engineering, Finance, People, and commercial teams. Form a clear view of the gaps and a prioritized plan for closing them.

First 3–6 months. Core policies and procedures drafted and rolling out. A practical testing and monitoring program stood up. Reporting, escalation, and governance cadence running, giving leadership a clear view of compliance risk. Registration preparation on track.

In 1 year. A compliance program that scales with the business: registrations supported, examinations and audits running smoothly, and teams involving compliance early — not only after a problem has occurred. The program manages risk practically, without unnecessary friction.

What you bring

  • Experience building a compliance program, standing up a major part of one, or materially improving how an existing program operates.
  • Broad compliance experience across several domains rather than a single speciality, with strong knowledge of how policies, controls, monitoring, testing, training, reporting, and governance work together.
  • Experience supporting regulatory registrations, examinations, audits, or similar engagements.
  • A willingness to work directly on the detail — you can both set the approach and execute it, without needing a mature compliance function around you to get started.
  • The ability to give clear, practical guidance without overcomplicating it: managing risk pragmatically rather than defaulting to the most conservative answer, while giving a clear “no” when the risk requires it.
  • Good judgement and the confidence to raise concerns directly when something does not look right.
  • Comfort working in a growing company where the priorities and regulatory questions will continue to evolve.

Bonus points

  • Experience in crypto, digital assets, or onchain financial products, and familiarity with the regulatory questions facing businesses operating across traditional and onchain finance.
  • A compliance designation such as CAMS, CRCM, or CCEP.
  • Existing experience working with relevant regulators.
  • Experience using AI, automation, or data tooling within a compliance program.

Benefits and Perks

  • Remote first - work from anywhere in the US & CAN!
  • Regular in-person company retreats and cross-country “office visit” perk
  • 100% paid medical, dental, and vision premiums for employees
  • $1,000 WFH stipend
  • Monthly reimbursement for home internet, phone, and cellular data
  • Unlimited vacation
  • 100% paid parental leave of 12 weeks
  • Fertility benefits
  • Opportunity for incentive compensation

The national pay range for this role is $200,000 - $240,000 base plus additional On Target Earnings potential by level and equity in the company. Our salary ranges are based on paying competitively for a company of our size and industry, and are one part of many compensation, benefits and other reward opportunities we provide. Individual pay rate decisions are based on a number of factors, including qualifications for the role, experience level, skill set, and balancing internal equity relative to peers at the company.

#LI-Remote

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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Legal Regulatory Attorney - Fully Remote | Upto $100/hr

Regulatory attorney advises on compliance, regulatory requirements, and legal matters for AI research operations.

Senior Remote Posted about 21 hours ago Himalayas
What this role involves
About the jobMercor connects elite creative and technical talent with leading AI research labs.
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Legal Corporate Law Expert - M&A Specialist

Provides expert legal counsel on mergers and acquisitions transactions for AI research organizations.

Senior Remote Posted about 21 hours ago Himalayas
What this role involves
About the jobMercor connects elite creative and technical talent with leading AI research labs.
Read the full description
Legal Legal Consultant – Structured Product / Global Markets

Provides legal support and expertise for structured products and global markets operations within a banking environment.

Mid Posted 1 day ago Jobicy AI
What this role involves
We are currently seeking a Legal Consultant with Structured Products/ Global Markets experience to join us and support our global banking client offering a collegiate and supportive environmentResponsibilities: Provide legal support...
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Legal Legal Consultant – Regulatory – Digital Assets, Payments

Lead regulatory strategy and compliance initiatives for cryptocurrency, stablecoins, and digital payment products.

Mid Posted 1 day ago Jobicy AI
What this role involves
We are currently seeking a Legal Consultant with experience in Cryptocurrency / Digital Payment to support our global fintech client:Responsibilities: Lead regulatory strategy for stablecoin / digital payment / asset...
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Legal Privacy Counsel

Provides legal counsel on privacy matters, ensuring compliance with data protection regulations and advising on privacy-related business decisions.

Mid Posted 1 day ago Jobicy AI
What this role involves
HackerOne is a global leader in Continuous Threat Exposure Management (CTEM). The HackerOne Platform unites agentic AI solutions with the ingenuity of the world’s largest community of security researchers to...
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Legal IP/Product Counsel at Chainguard

IP/Product Counsel manages intellectual property portfolio, enforces licensing compliance, and advises product teams on IP, open source licensing, and regulatory implications.

Mid Posted 2 days ago RemoteFirstJobs Product
What this role involves

Chainguard is the trusted source for open source. By delivering hardened, secure, and production-ready builds of all the open source software engineers and AI agents rely on, Chainguard helps organizations build faster, stay compliant, and eliminate risk.

Our customers include Fortune 500 enterprises and global industry leaders, including Anduril, Canva, Fortinet, Hewlett Packard Enterprise, OpenAI, Snap Inc., and Snowflake.

Chainguard is venture-backed by leading investors, including Amplify, IVP, Kleiner Perkins, Lightspeed Venture Partners, Mantis VC, Redpoint Ventures, Sequoia Capital, and Spark Capital.

The role, in a nutshell:

We’re looking for our first IP/Product Counsel to help Chainguard protect, monetize, and scale what we’re building. Chainguard moves quickly. As a result, open source licensing questions, product launch nuances, and IP protection are part of the day-to-day business, not occasional legal requests.

This role sits at the intersection of IP and product. You’ll manage our growing IP portfolio, lead enforcement efforts when our licensing terms are violated, and work closely with product and engineering teams as they build and launch new products and features.

This is a role with a significant runway. We’re not looking for someone to walk in and build a fully staffed function on day one. We’re looking for someone who can take ownership, build scalable processes, and grow the function over time.

The ideal candidate has a strong background in IP law, particularly open source licensing, trademark and copyright, with patent  and technology transactions experience as a plus. You’ll also have experience working closely with product teams, including drafting product terms, reviewing terms of service, and advising on the relevant privacy, licensing, and IP implications of new products and features.

You should be comfortable working across both sides of IP: proactively building protections for the company and enforcing those protections when needed. Fluency in open source licensing is required, including knowledge of standard permissive and copyleft licenses (e.g., MIT, Apache 2.0, BSD, GPL, LGPL, MPL) and non-standard (e.g. dual license) , as you’ll work with engineering teams on open source questions on a regular basis.

What You’ll Do:

  • Own and grow Chainguard’s international IP portfolio;
  • Lead IP enforcement efforts, including cease-and-desist actions involving customers or competitors who violate our licensing terms;
  • Serve as a go-to legal resource for open source licensing questions from engineering;
  • Advise product teams on licensing, IP, and terms of service considerations across multiple concurrent product and feature launches;
  • Draft and review product terms and terms of service for new launches;
  • Advise on licensing considerations in partner and joint development agreements;
  • Partner with product and engineering teams early in the development process to identify and address legal considerations before launch; and
  • Build scalable IP processes, templates, and resources as the function grows

What We’re Looking For:

  • 5+ years of legal experience with a strong foundation in IP law, including trademark and copyright; patent experience is a plus
  • Strong knowledge of open source licensing is highly valued, as these questions come up regularly in the role
  • Experience advising on product launches, product roadmaps, product terms, or terms of service is a plus, but not required
  • Strong IP experience can outweigh lighter product counsel experience
  • Comfort working both proactively to build and protect the company’s IP and reactively when enforcement is required
  • This is an individual contributor role today with the opportunity to grow into leading the function over time

Why This Role:

Chainguard recently experienced the busiest product launch stretch in company history. The pace isn’t slowing down, and neither are the IP and licensing questions that come with it.

This role will sit at the center of that work. You’ll help build the protections around what we’re creating, handle disputes when they arise, and partner directly with product and engineering teams before they ship.

As Chainguard continues to scale, so will this function. For the right person, there’s a real opportunity to shape how we approach IP and product counsel and potentially build and lead a team over time.

Base Salary Range

$200,000—$225,000 USD

About Us

We live and breathe our company values:

  • We are customer obsessed — We focus on delivering solutions to our customers that create value and make their lives better.
  • We have a bias for intentional action — We prioritize, plan, try things, and fail fast.
  • We don’t take ourselves too seriously (but we do serious work) — We are solving an important problem which takes focus, but we also like to enjoy the journey.
  • We trust each other and assume good intentions — We’re transparent with decisions to empower team members to make well informed decisions.

A few of the benefits we offer:

  • Flexible & Remote-First Culture: Work remotely with team meetup opportunities, bi-annual destination summits, and a monthly stipend for coworking spaces, phone and internet costs.
  • Our Approach to Equity: Receive stock options upon hire and promotion. Plus, you can participate in secondary offerings and have 10 years to exercise your options (yes, you read that correctly: 10 years!).
  • 100% Covered Health Insurance: We cover 100% of your health, vision and dental insurance premiums for you and your dependents. Nothing comes out of your paycheck.
  • ∞ Flexible Time Off: Take the time you need – to do our best work, we need to recharge and reset.
  • 18 Weeks Paid Parental Leave: We offer 18 weeks for birthing parents and 12 weeks for non-birthing parents, with the option to use it all at once or throughout your child’s first year.

If your experience is close but doesn’t fulfill all requirements, please apply. We’re building the best team in technology and are focused on hiring “Chainguardians” with unique backgrounds, perspectives, and experiences.

Chainguard is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law.

By submitting your application, you acknowledge that Chainguard will process your personal data in accordance with Chainguard’s Global Candidate Privacy Notice.

©2026 Chainguard. All Rights Reserved.

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Legal Executive Director, Medical Writing at Kyverna Therapeutics

Executive leader oversees medical writing strategy, regulatory documentation, and cross-functional collaboration for clinical-stage biopharmaceutical development and submissions.

Exec Hybrid Posted 2 days ago RemoteFirstJobs Product
What this role involves

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Title: Executive Director, Medical Writing

Reports to: Chief Regulatory Officer

Location: Emeryville (Hybrid) OR Remote (West coast hours preferred)

Position Summary

The Executive Director, Medical Writing serves as the functional lead for Medical Writing, providing strategic and operational leadership across the full product lifecycle. This role is responsible for establishing the vision, operating model, and capabilities of the Medical Writing function while ensuring the delivery of high-quality, scientifically rigorous, and submission-ready documentation that supports Kyverna’s development, regulatory, and commercialization objectives.

As a key member of the Regulatory leadership team, the Executive Director partners closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Pharmacovigilance, Quality, and Program Leadership to translate portfolio priorities into effective medical writing strategies and execution plans. This individual influences functional and portfolio decisions through operational expertise, identifies and mitigates regulatory documentation risks, and builds organizational capabilities that enable successful global submissions and lifecycle management.

Responsibilities

  • Lead the Medical Writing function, its strategic direction, operating model, and capabilities to support Kyverna’s evolving development portfolio.
  • Develop departmental goals and operational priorities aligned with organizational objectives and Regulatory Affairs strategies.
  • Serve as the functional representative on cross-functional governance and program teams, providing expert guidance on document strategy, planning, and execution.
  • Build a high-performing organization capable of supporting clinical development, regulatory submissions, and commercialization.
  • Provide executive oversight for the planning, development, review, and delivery of complex regulatory and scientific documents across all stages of product development and lifecycle management, including: Clinical study protocols, Investigator’s Brochures, Clinical Study Reports, INDs, BLAs, and other global regulatory submissions, Health Authority briefing packages and responses, Labeling support documents, Post-approval lifecycle management documentation, Safety and pharmacovigilance documentation, as applicable.
  • Partner with Regulatory Affairs leadership to develop integrated document strategies that support global submission objectives.
  • Provide scientific and regulatory guidance on complex content development, messaging, and submission readiness.
  • Ensure all documents meet applicable regulatory requirements and company quality standards.
  • Partner with senior leaders across Clinical Development, Regulatory Affairs, Biometrics, Clinical Operations, Medical Affairs, Pharmacovigilance, Quality, and Program Management to proactively identify documentation needs and execution risks.
  • Influence cross-functional planning by providing operational insight into submission strategy, resource requirements, timelines, and regulatory deliverables.
  • Lead resolution of complex issues affecting regulatory documentation quality, timelines, or submission readiness.
  • Represent Medical Writing during regulatory inspections, due diligence activities, and partner interactions, as appropriate.
  • Recruit, develop, and retain a high-performing Medical Writing organization.
  • Establish organizational structure, workforce planning, and succession strategies that support business growth.
  • Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement.
  • Coach and develop leaders within the function while establishing clear performance expectations and career development opportunities.
  • Develop and oversee departmental processes, standards, templates, metrics, and governance to ensure consistent, efficient execution.
  • Lead resource planning and capacity management across internal staff and external partners.
  • Oversee departmental budget planning and vendor strategy, ensuring appropriate utilization of external medical writing resources.
  • Drive continuous improvement initiatives that enhance quality, efficiency, scalability, and regulatory compliance.

Qualifications

  • Advanced degree in life sciences, pharmacy, medicine, or related discipline (PhD, PharmD, MD, or equivalent preferred).
  • 12+ years of progressive medical writing experience within the biotechnology or pharmaceutical industry, including significant leadership experience.
  • Demonstrated success leading Medical Writing organizations supporting global clinical development and regulatory submissions.
  • Deep understanding of global regulatory requirements and guidance (FDA, EMA, ICH) across the product lifecycle.
  • Experience supporting major regulatory submissions, including INDs, BLAs, MAAs, and lifecycle management activities.
  • Proven ability to influence cross-functional decision making and build collaborative relationships across senior leadership teams.
  • Experience developing organizational capabilities, leading organizational change, and scaling teams within a growing company.
  • Strong executive communication, leadership, and interpersonal skills.
  • Demonstrated ability to manage multiple complex programs while balancing strategic priorities with operational execution.

The national salary range for this position is $275K to $300K USD annually.   The salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock plan.

Read the full description
Legal Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid) at AbbVie

Develops and implements US/Canada regulatory strategy for aesthetics device products, managing FDA interactions and ensuring compliance throughout the product lifecycle.

Senior Hybrid Posted 2 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

  • This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
  • Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
  • Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
  • Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
  • Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
  • Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
  • Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Presents pertinent regulatory information to appropriate cross-functional teams.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

  • Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
  • 5+ years Regulatory, R&D, or equivalent industry-related experience.
  • Experience in medical device space
  • Experience with digital health/software
  • Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
  • Experience working in a complex and matrix environment.
  • Experience interfacing with government regulatory agencies.

Preferred Qualifications:

  • Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
  • Global regulatory experience is a plus.

Other Required Skills:

  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
  • Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid) at AbbVie

Develops and implements US & Canada regulatory strategy for aesthetics devices, manages FDA interactions, and ensures compliance with evolving regulatory requirements.

Senior Hybrid Posted 2 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

  • This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
  • Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
  • Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
  • Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
  • Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
  • Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
  • Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Presents pertinent regulatory information to appropriate cross-functional teams.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

  • Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
  • 5+ years Regulatory, R&D, or equivalent industry-related experience.
  • Experience in medical device space
  • Experience with digital health/software
  • Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
  • Experience working in a complex and matrix environment.
  • Experience interfacing with government regulatory agencies.

Preferred Qualifications:

  • Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
  • Global regulatory experience is a plus.

Other Required Skills:

  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
  • Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid) at AbbVie

Develops and implements US and Canada regulatory strategies for aesthetics devices, manages FDA interactions, and ensures compliance with evolving regulatory requirements.

Senior Hybrid Posted 2 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

  • This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
  • Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
  • Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
  • Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
  • Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
  • Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
  • Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Presents pertinent regulatory information to appropriate cross-functional teams.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

  • Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
  • 5+ years Regulatory, R&D, or equivalent industry-related experience.
  • Experience in medical device space
  • Experience with digital health/software
  • Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
  • Experience working in a complex and matrix environment.
  • Experience interfacing with government regulatory agencies.

Preferred Qualifications:

  • Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
  • Global regulatory experience is a plus.

Other Required Skills:

  • Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
  • Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Trade Compliance Specialist (Europe)

Ensures trade compliance and regulatory adherence for a diamond and gemstone marketplace operating across Europe.

Mid Remote Posted 2 days ago Jobicy AI
What this role involves
Location: Fully remote in EuropeWorking Hours: Mon – Fri, 9AM – 6PM CETAbout Nivoda 🚀Nivoda is a rapidly scaling global B2B diamond and gemstone marketplace connecting jewellery retailers with competitive,...
Read the full description
Legal Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC) - Hybrid at AbbVie

Manages Chemistry, Manufacturing & Control regulatory submissions for pharmaceutical products, authoring and compiling CMC documentation and coordinating across functional teams.

Senior Hybrid Posted 3 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Associate, RA CMC is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.  The Senior Associate will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.

Responsibilities:

  • Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.  Update simple CMC documents independently.
  • Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines.
  • Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently run team review and management reviews of submission documents.
  • Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
  • Provide input into and utilize current best practices for use of regulatory business systems within the group.
  • Timely communication of systems issues to management.
  • Communicate content gaps and risks for variation documents identified by RA CMC Project Leads.
  • Provide guidance on use of submission document templates.
  • Support annual reports and renewals (ad hoc baseline support)
  • This role works a hybrid work schedule (3 days in office & 2 days remotely) from the Lake County, IL; Waltham, MA or Irvine, CA AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
  • Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management
  • Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
  • Strong working knowledge of manufacturing unit operations or CTD structure
  • Superior oral and written communication skills
  • Ability to work cooperatively with all levels and types of global personnel required
  • Experience working with electronic document management systems
  • Ability to work independently under pressure and manage multiple projects simultaneously
  • Detail/accuracy oriented
  • Collaborative and willing to learn
  • Familiarity with US and other international regulatory requirements for drug product dossiers

Additional Information

​Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
  • This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid) at AbbVie

Develops and implements US and Canada regulatory strategies for pharmaceutical products, manages FDA interactions, and ensures compliance with regulatory requirements.

Senior Hybrid Posted 3 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

  • Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
  • Assigned matters may have a moderate impact on business activities and operations.
  • Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
  • Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
  • Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
  • Assists in the development, training of staff members.
  • Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
  • Supports the regulatory submission and approval process.
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
  • Presents pertinent regulatory information to appropriate cross-functional areas.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

  • Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
  • 6 years Regulatory, R&D, or Industry-related experience.
  • Experience working in a complex and matrix environment.
  • Experience interfacing with government regulatory agencies.

Preferred Qualifications:

  • 2-3 years in pharmaceutical regulatory activities
  • Global regulatory experience is a plus.
  • Advanced Degree a plus
  • Certifications a plus

Other Required Skills:

  • Excellent negotiation skills, problem solving skills and builds consensus.
  • Effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.
  • Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid) at AbbVie

Develops and implements US and Canada regulatory strategy for pharmaceutical products, manages FDA interactions, and ensures compliance with health authority requirements.

Senior Hybrid Posted 3 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

  • Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
  • Assigned matters may have a moderate impact on business activities and operations.
  • Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
  • Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
  • Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
  • Assists in the development, training of staff members.
  • Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
  • Supports the regulatory submission and approval process.
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
  • Presents pertinent regulatory information to appropriate cross-functional areas.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

  • Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
  • 6 years Regulatory, R&D, or Industry-related experience.
  • Experience working in a complex and matrix environment.
  • Experience interfacing with government regulatory agencies.

Preferred Qualifications:

  • 2-3 years in pharmaceutical regulatory activities
  • Global regulatory experience is a plus.
  • Advanced Degree a plus
  • Certifications a plus

Other Required Skills:

  • Excellent negotiation skills, problem solving skills and builds consensus.
  • Effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.
  • Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid) at AbbVie

Develops and implements US and Canada regulatory strategies for immunology products, manages FDA communications, and ensures compliance with regulatory requirements.

Senior Hybrid Posted 3 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

  • Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
  • Assigned matters may have a moderate impact on business activities and operations.
  • Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
  • Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
  • Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
  • Assists in the development, training of staff members.
  • Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
  • Supports the regulatory submission and approval process.
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
  • Presents pertinent regulatory information to appropriate cross-functional areas.
  • Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

  • Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
  • 6 years Regulatory, R&D, or Industry-related experience.
  • Experience working in a complex and matrix environment.
  • Experience interfacing with government regulatory agencies.

Preferred Qualifications:

  • 2-3 years in pharmaceutical regulatory activities
  • Global regulatory experience is a plus.
  • Advanced Degree a plus
  • Certifications a plus

Other Required Skills:

  • Excellent negotiation skills, problem solving skills and builds consensus.
  • Effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.
  • Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Regulatory Attorney - Fully Remote | Upto $100/hr

Regulatory attorney advising on compliance, legal frameworks, and policy matters for AI research or tech organization.

Senior Remote Posted 3 days ago Himalayas
What this role involves
About the jobMercor connects elite creative and technical talent with leading AI research labs.
Read the full description
Legal Management Systems Auditors

Audits management systems to verify compliance with quality, environmental, and sustainability standards for TIC service clients.

Mid Posted 3 days ago Himalayas
What this role involves
About the ClientOur client is a globally recognized leader in Testing, Inspection, and Certification (TIC) services, supporting organizations worldwide in achieving high standards of quality, environmental performance, energy efficiency, compliance, and sustainability.
Read the full description
Legal Corporate Counsel

Provides legal counsel and guidance for a legal AI company on a part-time contractor basis.

Senior Remote Posted 3 days ago Himalayas
What this role involves
Role Title: Corporate Counsel Job Type: Contractor Location: Remote Job Summary:We are seeking seasoned in-house Corporate Counsels for a part-time role at the forefront of legal AI.
Read the full description
Legal Senior Regulatory Permitting Specialist at WRA

Senior regulatory specialist develops permitting strategies, coordinates multidisciplinary teams, and guides clients through California's environmental and infrastructure regulatory processes.

Senior Hybrid Posted 4 days ago RemoteFirstJobs Product
What this role involves

We’re currently hiring a Senior Regulatory Permitting Specialist in the Sacramento/Central Valley region. On Team 12, you will work closely with WRA’s Principals, Directors, and Executive-level leadership to develop, manage, and deliver multifaceted regulatory projects primarily in California’s Central Valley and Foothills region. WRA is committed to growing in the Sacramento and San Joaquin Valleys and Foothills as a focus of our 2030 strategic plan, and this hire will support existing senior-level staff in that goal.

In this role you will work collaboratively between clients, regulators, and an interdisciplinary WRA team to develop innovative approaches, lead interesting consultation processes, and support project implementation. This is a remote position within the state of California,: however, the person hired for this role will be expected to be at various on-site locations including field sites, client or agency offices in the greater Sacramento and Central Valley area. Occasional visits to WRA’s office locations are also expected as needed to meet project needs. This role reports to Rob Schell, Wildlife and Fisheries Director.

In this role, you will:

  • Work with Principals as well as Director and Executive-level staff, including subject matter experts, engineers, attorneys, clients, prime or subconsultants to develop a project from idea, through planning and permit consultations in support of critical infrastructure and development in California’s Central Valley and Foothills

  • Merge technical expertise with regulatory experience to guide and advise clients on project due diligence, design, opportunities and constraints to develop and deliver a permitting strategy, schedule, and budget that reflects client priorities

  • Coordinate, delegate, and oversee multidisciplinary teams, stakeholders, staff, and subconsultants on the preparation of technical studies necessary to support the permitting process

  • Oversee or directly prepare permit applications

  • Proactively manage budgets, prepare scopes of work and change orders.

  • Identify and communicate project risks to Principal-level staff

  • Oversee and mentor early career professionals on regulatory processes, project management, and professional development

  • Participate in internal and external thought leadership at conferences or professional technical groups through publications, presentations, white papers, panel discussions, or similar

To be successful in this role, you will need:

  • A bachelor’s degree in biological sciences, engineering, policy, or related field

  • At least 10 years of professional experience working in the consulting field

  • At least 6 years of expertise preparing and consulting on 401, 404, 1600 LSAA, USFWS/NMFS Section 7 or Section 10 consultations, CDFW 2081 ITPs

  • Proven experience building and managing across multidisciplinary teams

  • Proven track record in a supervisory or leadership role

  • Demonstrated experience in Transportation, Water, or Mine/Quarry Markets

  • At least 5 years of project management experience, including preparing scopes of work, budgets and change orders

  • At least 5 years working in California’s Central Valley or Foothills regions

  • A growth mindset

  • Strong written and verbal communication skills, with the ability to present technical information to a lay audience

  • A valid driver’s license, reliable transportation (while WRA has fleet vehicles that can be reserved for field use, during busy field seasons a truck may not always be available) and willingness to travel to field sites and meetings

  • The ability to walk, hike, and work outside for long periods of time

Desired but not required skills:

  • Specialized expertisewith Mitigation, SMARA, FERC

  • Business Development experience

  • Experience working on competitive proposals

  • Strong leadership skills

WRA has an established internal leveling system for our staff that maps to salary bands that have been informed by market data. Our leveling system is dependent on years of relevant industry experience, education, and the level of responsibility and autonomy at which you’re expected to operate.

The salary range for this position is $108,000 - $146,000 which represents 2 job levels that WRA is open to considering for this role. In your first conversation with our recruiter, you may discuss leveling and compensation to make sure that expectations are aligned. Additionally, while the position is being advertised as a Senior Regulatory Permitting Specialist, based on leveling conversations, we may determine that Regulatory Permitting Specialist is the appropriate title for you. There will be opportunities to discuss this toward the end of the interview process; however, if you wish to discuss titles earlier in the interview process, please do so with your recruiter.

Who are we?

WRA’s an employee-owned environmental consultancy. We are a tenacious team of planners, engineers, and scientists, and we aim to leave the lands we love better than we found them.

Our clients and partners hire us because we’re skilled at navigating through challenging projects involving wildlands, parks, community spaces, and infrastructure. We bring over four decades of expertise, long-standing relationships, and connections to our local communities to make sure that projects are pursued in responsible ways where both people and the environment thrive.

As an organization, we believe that independence and interdependence are not mutually exclusive. We invest in systems, processes, and employee programs to support our staff’s collective engagement and success. At the same time, we encourage our employees to operate with an ownership mindset, taking responsibility for outcomes and being true to our commitments.

WRA’s company vision is to cultivate a sustainable future where people and the environment thrive, and that effort starts first with our staff. We are committed to building a diverse, equitable, and inclusive work environment, and we have developed flexible policies, internal practices, and are investing in programs that prioritize learning and sustainability. We aim to create conditions that allow employees to prioritize their families, lead healthy and balanced lives, and to bring their authentic selves to work every day. We believe that by creating an exceptional workplace, our employees will be able to do their best work and be able to meaningfully contribute to the sustainability of the environment and the communities in which we live.

WRA is an equal opportunity employer, and we are committed to creating a diverse environment. We recruit, employ, train, compensate and promote regardless of race, religion, color, national origin, gender, sexual orientation, disability, age, veteran status, and other protected status as required by applicable law.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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