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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$135K - $160K *

Empower innovation by leading global regulatory strategies that drive compliance and growth. Collaborate with executive leadership to shape product stewardship and sustainability initiatives across di...

3 days ago

  •   11 - 15 years exp.  •   Retail & Consumer Goods

$230K - $270K *

Shape CMC regulatory strategy for innovative Allogeneic CAR T programs, ensuring compliance and quality throughout development and registration processes. Lead interactions with global regulatory agen...

4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$81K - $103K *

Optimize quality assurance processes in a dynamic environment, ensuring compliance with GMP regulations. Collaborate with cross-functional teams to enhance documentation, training, and quality metrics...

Reposted 2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$107K - $138K *

Join a dynamic team to enhance Quality Control lab operations through innovative digital solutions and systems integration, driving compliance and efficiency in a GMP-regulated environment while colla...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$96K - $167K *

Join a team that's shaping global regulatory strategies in the medical device sector. You'll lead a talented group through complex landscapes, driving innovation while ensuring compliance and successf...

Reposted 5 days ago

  •   5 - 7 years exp.  •   Healthcare

$80K - $95K *

Lead supplier quality initiatives by auditing processes, ensuring compliance, identifying defects, and driving corrective actions to enhance product quality and supplier performance while fostering st...

4 weeks ago

  •   Less than 5 years exp.  •   Enterprise Technology

$175K - $283K *

Lead the charge in Regulatory CMC for small molecule programs, driving strategic initiatives and global submissions. Collaborate with cross-functional teams to ensure compliance and support successful...

Today

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$175K - $283K *

Champion regulatory excellence by leading CMC strategies for small molecule programs, ensuring compliance and driving successful submissions from early development through commercialization in a dynam...

United StatesRemote

Today

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$86K - $165K *

Shape the future of records management by developing processes and systems that enhance compliance and efficiency. Collaborate with teams to assess needs, analyze data, and promote best practices in r...

Texas, USRemote

2 days ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$81K - $101K *

Oversee quality assurance activities, ensuring compliance and product integrity. Execute QMS processes, manage product complaints, support DSCSA adherence, and collaborate with cross-functional teams...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$135K - $160K *

Unlock potential by leading global quality strategies for home and personal care products, overseeing compliance, enhancing product safety, and driving continuous improvement across regions while fost...

Reposted 4 days ago

  •   8 - 10 years exp.  •   Retail & Consumer Goods

$110K - $130K *

Oversee materials compliance and quality assurance for large-scale projects, ensuring adherence to policies and federal regulations. Provide technical leadership on complex compliance issues while man...

2 weeks ago

  •   8 - 10 years exp.  •   Real Estate & Construction

$110K - $130K *

Elevate compliance standards by providing expert guidance on FDA CGMP regulations, advising clients on inspection readiness, and collaborating with cross-functional teams to ensure adherence to qualit...

Yesterday

  •   5 - 7 years exp.  •   Legal & Accounting

$207K - $253K *

Elevate regulatory excellence by leading global CMC strategies for cell therapy products, ensuring compliance from development through commercialization while managing risks and fostering cross-functi...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$230K - $250K *

Pioneer innovative regulatory strategies for global clinical development, leading cross-functional teams and ensuring compliance with health authority requirements. Drive submissions and represent the...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Transform regulatory compliance and pharmacy operations by overseeing licensing, accreditation, and audits. Collaborate with clinical leaders to develop scalable practices while ensuring adherence to...

1 week ago

  •   8 - 10 years exp.  •   Hospitals & Medical Centers

$80K - $105K *

Lead regulatory operations by overseeing submissions, enhancing processes, and mentoring the team. Ensure compliance and accuracy while managing multiple priorities in a dynamic, remote environment. D...

United StatesRemote

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$116K - $174K *

Lead the development and oversight of a Quality Learning and Development program, ensuring compliance with regulatory standards while collaborating cross-functionally to enhance training processes and...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$88K - $121K *

Engage as a key quality partner, ensuring compliance and driving improvements across quality systems, investigations, audits, and product release activities to deliver safe, high-quality products in a...

Today

  •   5 - 7 years exp.  •   Healthcare

$88K - $121K *

Drive quality excellence by ensuring compliance and effectiveness in quality systems. Collaborate across teams to manage investigations, audits, and product release, while supporting continuous improv...

2 days ago

  •   5 - 7 years exp.  •   Healthcare

$75K - $111K *

Transform the regulatory landscape by preparing applications and ensuring compliance with Canadian medical device regulations while collaborating across teams to drive project success and maintain hig...

Mississauga, ONIn-Person

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$85K - $100K *

Champion quality assurance excellence in cGMP manufacturing, ensuring compliance and product integrity. Engage in diverse QA tasks, from documentation to inspections, while driving continuous improvem...

2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$85K - $100K *

Unlock potential by overseeing quality assurance activities in cGMP manufacturing. Drive compliance and excellence in documentation, product disposition, and quality systems while collaborating on pro...

2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Transform your career by driving high-impact opportunities through advanced technical selling and market development. Collaborate with Central Sales to shape customer workflows and accelerate adoption...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Join us to drive high-impact opportunities through advanced technical selling and market development. Collaborate with Central Sales to shape customer workflows, enhance adoption, and create strategic...

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.