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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$76K - $121K *

Optimize compliance and investigations in cGMP for cell therapy development. Lead root cause analysis, CAPA development, and quality system performance monitoring while collaborating cross-functionall...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$222K - $303K *

Lead the charge in developing and implementing global CMC regulatory strategies for gene therapy, ensuring compliance and facilitating efficient product development from early stages through registrat...

Reposted today

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$222K - $303K *

Transform your career by leading global CMC regulatory strategies for gene therapy. Collaborate with cross-functional teams to navigate complex regulatory landscapes, ensuring compliance and driving i...

San Diego, CARemote

Reposted today

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$150K - $245K *

Empower your career by leading regulatory advertising initiatives, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging for marketed and pipeline...

United StatesRemote

Today

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$106K - $197K *

Join a dynamic team to shape regulatory strategies for innovative diagnostics. Collaborate across functions to navigate complex regulatory environments, ensuring patient access to cutting-edge patholo...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$106K - $197K *

Shape the future of diagnostics by overseeing regulatory projects and strategies for innovative pathology solutions. Collaborate across functions to navigate complex regulations and enhance patient ac...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$106K - $197K *

Reimagine regulatory pathways in diagnostics by leading global submissions and strategies. Collaborate across functions to enhance patient access to innovative solutions while navigating complex regul...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Champion global regulatory strategies for medical devices in surgery and dermatology. Lead cross-functional teams, ensuring compliance with FDA and EU regulations while managing submissions and intera...

4 days ago

  •   8 - 10 years exp.  •   Healthcare

$142K - $256K *

Lead the charge in developing and executing CMC regulatory strategies for international submissions, ensuring compliance and guiding teams through complex regulatory landscapes in a dynamic, results-d...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Help us advance procurement excellence in biologics by managing supplier relationships and ensuring efficient sourcing processes, while collaborating across teams to enhance operational success and dr...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Lead regulatory intelligence efforts, ensuring compliance and strategic guidance across global frameworks, with a focus on containment systems and pharmaceutical operations in a collaborative, fast-pa...

Reposted 2 days ago

  •   5 - 7 years exp.  •   Healthcare

$71K - $97K *

Champion the training program and document control initiatives, ensuring compliance and effectiveness in quality systems. Collaborate with teams to enhance training materials and support onboarding, w...

2 days ago

  •   Less than 5 years exp.  •   Healthcare

$100K - $151K *

Take ownership of quality assurance processes, ensuring compliance with GMP regulations and driving corrective actions. Collaborate across technical operations to maintain high standards in product ma...

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $155K *

Join a team that's dedicated to ensuring vaccine quality and safety by overseeing compliance and operational excellence in aseptic manufacturing processes. Collaborate with experts and CMOs to drive c...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$117K - $184K *

Unlock your potential as a key leader in device design control, driving innovative product development and lifecycle management. Collaborate with cross-functional teams to ensure high-quality outcomes...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$90K - $110K *

Join a team that's committed to ensuring global trade compliance excellence through strategic oversight and process improvement, while guiding stakeholders in navigating complex regulatory landscapes...

Reposted 2 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$180K - $235K *

Champion regulatory excellence by leading strategic submissions and technical writing efforts. Collaborate cross-functionally to ensure compliance with global standards while driving process improveme...

Today

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$88K - $116K *

Support the Quality Management System by reviewing and approving key documentation, ensuring compliance with regulations. Champion best practices in discrepancy reporting and CAPA processes while coll...

Reposted 4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$106K - $159K *

Optimize trade compliance processes by leveraging analytics and collaboration across teams. Drive continuous improvement initiatives while ensuring adherence to customs regulations and enhancing opera...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$160K - $200K *

Champion global regulatory strategies by providing expert support from development to approval. Lead cross-functional teams and ensure compliance with US and international regulations while fostering...

United StatesRemote

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Join a dynamic team to lead the review of complex batch records ensuring compliance and quality excellence. Mentor junior specialists and drive continuous improvement within a regulated environment wh...

Reposted 3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Lead the charge in ensuring safety compliance and operational integrity for National Airspace System (NAS) operations through specialized analysis and collaboration with cross-functional teams...

4 weeks ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$80K - $115K *

Transform cancer therapy development by leading pharmacovigilance efforts. Collaborate with cross-functional teams to ensure regulatory compliance and manage serious adverse events, contributing to in...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $115K *

Explore a pivotal role in pharmacovigilance, ensuring regulatory compliance and safety management for cancer therapies. Collaborate with cross-functional teams to enhance drug safety processes and sup...

Princeton, NJRemote

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$125K - $150K *

Drive regulatory strategy across major programs, leading high-impact submissions and authority engagement. Collaborate with cross-functional teams to optimize clinical development and ensure complianc...

United StatesRemote

1 week ago

  •   8 - 10 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.