Senior Regulatory Affairs Specialist Jobs

Explore senior regulatory affairs specialist jobs with organizations seeking experienced professionals to guide products through complex regulatory requirements. These roles combine subject-matter expertise, strategic judgment, and cross-functional leadership to support compliant product development and market access. Ladders features vetted professional opportunities paying $100,000 or more.

What Senior Regulatory Affairs Specialists Do

Senior regulatory affairs specialists interpret regulations and guidance, assess how requirements affect products and business plans, and coordinate regulatory activities across the product lifecycle. Depending on the industry, they may prepare and review submissions, maintain regulatory documentation, support audits and inspections, and communicate with regulatory agencies. They also help teams identify risks early and keep programs aligned with applicable standards.

Common Responsibilities and Skills

Responsibilities vary by employer and sector, but often include developing regulatory strategies, managing submission timelines, reviewing technical and labeling materials, tracking regulatory changes, and advising partners in quality, clinical, research, manufacturing, and commercial teams. Employers may look for strong writing and project-management skills, careful attention to detail, sound judgment, and experience with relevant regulations and submission processes.

Industries and Career Opportunities

Senior regulatory affairs specialists work across fields such as pharmaceuticals, biotechnology, medical devices, diagnostics, and other regulated industries. Their experience can lead to opportunities in regulatory strategy, program leadership, regulatory operations, quality, or people management. Scope and job requirements depend on the organization, product type, and markets served.

Find Senior Regulatory Affairs Specialist Jobs

Browse senior regulatory affairs specialist opportunities on Ladders to discover vetted roles paying $100,000 or more. Compare responsibilities, qualifications, and work arrangements, then focus your search on positions that match your regulatory expertise and career goals.

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$150K - $180K *

Deliver strategic regulatory leadership for global development programs, overseeing regulatory strategy and execution from late-stage clinical phases to marketing authorization while ensuring complian...

North Carolina, USRemote

Reposted 4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Take ownership of environmental compliance initiatives by developing water quality plans, leading fieldwork, and analyzing data to ensure regulatory adherence and support project management efforts in...

1 week ago

  •   5 - 7 years exp.  •   Real Estate & Construction

$80K - $95K *

Oversee regulatory compliance for chemical products, ensuring adherence to TSCA and federal/state regulations. Collaborate with cross-functional teams to provide guidance, manage submissions, and main...

3 days ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$139K - $184K *

Lead regulatory compliance programs ensuring inspection readiness and proactive risk management across cross-functional teams. Monitor compliance health, manage data quality, and drive improvements al...

United StatesRemote

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$125K - $177K *

Advance your career by supporting essential regulatory operations and submissions. Collaborate across teams to ensure compliance and maintain high-quality regulatory documentation, driving initiatives...

Reposted 4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Take ownership of IMP labeling processes, ensuring compliance with global regulations and quality standards while collaborating cross-functionally to support clinical trial timelines and enhance label...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Drive quality excellence by leading compliance initiatives, mentoring teams, and enhancing quality systems. Collaborate across functions to mitigate risks and ensure regulatory readiness while fosteri...

1 week ago

  •   Less than 5 years exp.  •   Business Services

$153K - $268K *

Join a team that's advancing regulatory strategies for drug substance manufacturing. Lead the charge in selecting and justifying Regulatory Starting Materials, ensuring compliance with global guidelin...

United StatesRemote

Reposted yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$164K - $282K *

Shape the future of regulatory affairs by leading North American strategies, ensuring compliance, and driving innovation in drug development. Collaborate with cross-functional teams to influence polic...

4 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$164K - $282K *

Shape regulatory strategies for North America, leading a dynamic team to ensure compliance and drive innovation in drug development. Collaborate cross-functionally to influence policies and manage sub...

4 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$164K - $282K *

Optimize regulatory strategies as a leader in North America, guiding cross-functional teams to ensure compliance and drive innovation in drug development while managing key interactions with health au...

4 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$109K - $174K *

Take ownership of regulatory strategies for product lifecycle management, guiding cross-functional teams in submissions and compliance. Drive innovation in wound closure solutions, ensuring timely mar...

Raritan, NJRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$114K - $212K *

Transform compliance standards by leading site inspections and audit readiness. Drive a robust Quality Culture, ensuring continuous improvement and operational excellence in aseptic drug product manuf...

5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Drive regulatory excellence by supporting global product launches and site registrations. Collaborate cross-functionally to enhance processes, draft documentation, and improve efficiency in a fast-pac...

Yesterday

  •   Less than 5 years exp.  •   Healthcare

$56K - $115K *

Accelerate global regulatory CMC strategy and submissions for marketed products, ensuring compliance with FDA, EMA, Health Canada, and ICH guidelines. Collaborate cross-functionally as a primary conta...

RemoteRemote

4 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$56K - $115K *

Pioneer regulatory CMC strategies while leading cross-functional teams in the pharmaceutical industry. This role will focus on lifecycle management and submissions across US, CA, and EU markets, ensur...

Massachusetts, USRemote

4 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$56K - $115K *

Advance regulatory strategy and submissions for CMC in pharmaceuticals, collaborating with cross-functional teams to ensure compliance with FDA, EMA, and ICH standards while overseeing product lifecyc...

RemoteRemote

4 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Champion regulatory excellence by leading global submissions and compliance for medical devices. Collaborate with cross-functional teams to ensure adherence to standards while driving strategic initia...

1 week ago

  •   8 - 10 years exp.  •   Healthcare

$150K - $175K *

Transform complex clearinghouse functionalities into impactful product features, driving cross-functional collaboration and enhancing platform capabilities. Mentor peers while independently managing h...

1 week ago

  •   5 - 7 years exp.  •   Finance & Insurance

$110K - $130K *

Empower regulatory excellence by managing promotional materials compliance across global markets, ensuring adherence to laws and internal policies, while aligning with strategic business objectives in...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$150K - $175K *

Drive the development of high-impact clearing solutions, owning complex workstreams and collaborating across teams. Leverage expertise to enhance product delivery, mentor peers, and influence strategi...

1 week ago

  •   5 - 7 years exp.  •   Finance & Insurance

$220K - $300K *

Join a team that's driving innovative regulatory strategies for oncology therapeutics. Collaborate across global development teams to ensure compliance and achieve rapid approvals, leveraging your exp...

3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$130K - $155K *

Shape regulatory strategies for US & Canada, ensuring compliance and successful product lifecycle management in the aesthetics device sector. Collaborate with cross-functional teams and health authori...

3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$140K - $175K *

Unlock your potential as a regulatory leader, driving CMC strategies and ensuring compliance at a key manufacturing site. Collaborate globally to navigate complex regulatory landscapes and support inn...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$76K - $121K *

Deliver compliance leadership in cGMP investigations, ensuring quality and regulatory standards are met while driving continuous improvement in cell therapy development and clinical manufacturing proc...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

Frequently Asked Questions (FAQ)

  • What does a senior regulatory affairs specialist do?question toggle

    A senior regulatory affairs specialist interprets applicable regulations, develops or supports regulatory strategies, coordinates submissions and documentation, and advises cross-functional teams on compliance throughout a product's lifecycle.

  • What qualifications are commonly required for senior regulatory affairs specialist jobs?question toggle

    Employers commonly seek relevant regulatory affairs experience, familiarity with regulations for the applicable industry and markets, strong written communication, project-management ability, and a related degree. Specific requirements vary by role and product area.

  • Which industries hire senior regulatory affairs specialists?question toggle

    Common employers include pharmaceutical, biotechnology, medical device, and diagnostics companies, as well as other organizations that develop or manage regulated products.

  • How much do senior regulatory affairs specialist jobs pay?question toggle

    Pay varies by employer, location, industry, and experience. Ladders focuses on vetted professional jobs paying $100,000 or more.

  • What career paths can follow a senior regulatory affairs specialist role?question toggle

    Experienced specialists may advance into regulatory strategy, regulatory program or operations leadership, management, or related quality and compliance roles, depending on their background and the employer.