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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$110K - $130K *

Join a dynamic team to shape innovative regulatory solutions in healthcare. Drive product strategy from discovery to launch, leveraging AI and emerging technologies to meet market needs and enhance cu...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$134K - $219K *

Transform data stewardship by overseeing enterprise data-quality monitoring, ensuring compliance with standards, and providing actionable insights for leadership. Collaborate across functions to enhan...

5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$127K - $165K *

Unlock potential by leading regulatory strategies for innovative medical devices. Collaborate with teams to ensure compliance, execute FDA submissions, manage project timelines, and establish processe...

RemoteRemote

Reposted today

  •   8 - 10 years exp.  •   Healthcare

$154K - $242K *

Join a dynamic team to shape regulatory capability strategies, ensuring alignment across business and technology. Drive enhancements in regulatory systems, optimize processes, and support cross-functi...

2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$154K - $242K *

Drive regulatory capability strategy by collaborating with cross-functional teams to translate needs into scalable system solutions, enhancing compliance and efficiency across business processes and t...

2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$129K - $156K *

Shape the future of GMP Document Control by managing end-to-end governance, ensuring compliance with regulatory standards, and driving continuous improvement in documentation and records management pr...

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$235K - $265K *

Shape the future of global regulatory strategy for biologics by leading negotiations, driving approvals, and influencing cross-functional partnerships across multiple markets, ensuring compliance and...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$125K - $150K *

Transform regulatory compliance in plasma operations by directing submissions, fostering relationships with health authorities, and ensuring adherence to national and international standards. Drive st...

Toronto, ONIn-Person

Reposted 3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Lead the charge in developing global regulatory strategies to secure market approval for products. Collaborate with cross-functional teams, manage regulatory risks, and ensure compliance throughout th...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$154K - $209K *

Champion strategic initiatives to drive product utilization in Allergy/Immunology. Build relationships with key healthcare professionals and collaboratively address customer needs while analyzing mark...

4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join a team that's enhancing technical product content to drive revenue growth. You'll manage product launches, apply scientific expertise, and collaborate across divisions to ensure accurate, discove...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Optimize supplier quality and compliance by leading assessments, audits, and performance management. Collaborate with cross-functional teams to drive continuous improvement and ensure the delivery of...

2 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$110K - $130K *

Shape the future of quality assurance by leading strategic initiatives and fostering a proactive culture. Drive compliance and continuous improvement in a dynamic environment, collaborating across tea...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$102K - $194K *

Shape the future of medical technology by leading IEC 60601 compliance for new product development. Collaborate with cross-functional teams to ensure safety and effectiveness in innovative medical dev...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$88K - $105K *

Join a dynamic team to optimize and validate processes for commercial products, ensuring compliance and efficiency. Leverage your technical expertise in pharmaceutical manufacturing to drive innovatio...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Transform the quality landscape in software development by leading a robust Quality Management System, ensuring compliance with regulatory standards while fostering modern engineering practices for he...

2 weeks ago

  •   5 - 7 years exp.  •   Enterprise Technology

$62K - $97K *

Transform compliance and safety protocols in a dynamic environment, ensuring adherence to regulatory standards while fostering a culture of safety and efficiency. Collaborate with teams to enhance ope...

Fife, WAIn-Person

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$133K - $172K *

Drive regulatory CMC leadership for global CAR T cell therapy, ensuring compliance and alignment with business objectives. Collaborate with cross-functional teams to manage submissions and lifecycle s...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$133K - $172K *

Join a team that's shaping the future of CAR T cell therapy by leading global regulatory CMC efforts. Drive submissions, lifecycle management, and cross-functional collaboration to ensure compliance a...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$133K - $172K *

Unlock potential by leading global regulatory CMC efforts for CAR T cell therapies. Collaborate with cross-functional teams to ensure compliance and drive successful submissions, lifecycle management...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$75K - $94K *

Champion quality standards by driving compliance and improvement initiatives within the QMS framework. Oversee inspections, audits, and training while collaborating with teams to ensure regulatory adh...

Reposted 3 days ago

  •   Less than 5 years exp.  •   Healthcare

$130K - $155K *

Drive regulatory strategies and compliance for high-risk medical devices, ensuring successful market approval and navigating complex global regulations while collaborating with cross-functional teams...

Reposted 2 weeks ago

  •   11 - 15 years exp.  •   Healthcare

$88K - $116K *

Join a dynamic team as you drive accurate product classification for imports and exports, ensuring compliance and optimizing duties. Collaborate across departments to enhance trade operations and main...

Washington, USRemote

3 days ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$97K - $130K *

Unlock potential by driving supplier compliance and continuous improvement. Collaborate with cross-functional teams to ensure quality standards and regulatory requirements are met, while managing supp...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$160K - $200K *

Deliver strategic regulatory leadership across North America, guiding a dedicated team to ensure compliance and support business growth. Drive innovation by translating food regulations into practical...

Reposted 1 week ago

  •   11 - 15 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.