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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$140K - $180K *

Elevate your career by driving market growth in High-Plex Sequencing. Collaborate with research and clinical customers to develop strategies, optimize workflows, and establish yourself as a trusted te...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$140K - $180K *

Drive market growth as a High-Plex Sequencing Sales Specialist, leveraging your NGS expertise to shape strategies, build relationships, and influence adoption of innovative library prep solutions acro...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $138K *

Transform clinical research by leading site management for phase II-IV trials. Collaborate with a dedicated team to ensure compliance, efficiency, and quality in Dermatology & Rare Disease studies whi...

RemoteRemote

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$95K - $115K *

Champion clinical trial excellence by overseeing monitoring activities, ensuring compliance with protocols and regulations, and fostering collaboration across teams to drive successful outcomes and co...

4 days ago

  •   5 - 7 years exp.  •   Healthcare

$100K - $120K *

Lead clinical trial monitoring efforts, ensuring compliance with protocols and regulations while fostering collaboration across teams to enhance data integrity and site performance...

Blue Bell, PARemote

5 days ago

  •   5 - 7 years exp.  •   Healthcare

$80K - $95K *

Join a team that's dedicated to advancing clinical research by monitoring trials, ensuring compliance with protocols and regulations, and contributing to the success of innovative healthcare solutions...

Montreal, QCIn-Person

6 days ago

  •   Less than 5 years exp.  •   Healthcare

$108K - $135K *

Lead the charge in clinical research by monitoring trials, ensuring compliance with protocols and regulations, and enhancing patient safety. Collaborate with teams to drive successful outcomes in drug...

Montreal, QCIn-Person

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$108K - $135K *

Elevate your career by ensuring clinical trials meet regulatory standards and protocols. As a key player, you'll monitor studies, collaborate with teams, and contribute to life-saving research in a dy...

Burlington, ONIn-Person

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$119K - $126K *

Pioneer compliance and certification processes for airborne systems, ensuring adherence to airworthiness standards. Collaborate with cross-functional teams to deliver comprehensive certification docum...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$173K - $272K *

Lead the charge in ensuring quality oversight for contract testing laboratories globally, implementing policies and managing performance to meet regulatory standards while safeguarding patient safety...

RemoteRemote

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$77K - $118K *

Elevate your drafting career by collaborating in a dynamic team, utilizing advanced CAD tools, and gaining hands-on experience in 3D design. Contribute to innovative projects that shape the future of...

United StatesRemote

1 week ago

  •   8 - 10 years exp.  •   Technical Services

$95K - $115K *

Lead compliance initiatives within the Claims department, ensuring adherence to laws and regulations. Monitor regulatory changes, implement policies, conduct audits, and serve as the primary liaison w...

2 weeks ago

  •   5 - 7 years exp.  •   Finance & Insurance

$95K - $115K *

Drive compliance excellence in the Claims department by ensuring adherence to laws and regulations. Oversee audits, implement policies, and serve as the liaison with regulatory bodies to maintain high...

2 weeks ago

  •   5 - 7 years exp.  •   Finance & Insurance

$95K - $115K *

Join a team that's dedicated to ensuring compliance within the Claims department. You'll monitor regulations, implement policies, conduct audits, and liaise with regulatory authorities to uphold indus...

2 weeks ago

  •   5 - 7 years exp.  •   Finance & Insurance

$95K - $115K *

Grow your career with a pivotal role ensuring compliance in the Claims department. Monitor regulations, implement policies, conduct audits, and liaise with authorities to uphold industry standards and...

2 weeks ago

  •   5 - 7 years exp.  •   Finance & Insurance

$71K - $103K *

Join a team that's dedicated to advancing protein purification processes and diagnostics. Collaborate with scientists to develop robust systems, troubleshoot challenges, and present findings that driv...

3 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$70K - $99K *

Analyze and interpret complex materials testing data to support product development and quality decisions. Collaborate with cross-functional teams to enhance testing methods and drive materials innova...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Empower compliance by leading initiatives in Data, Records, and Information Management. Oversee projects ensuring adherence to federal laws, analyze program effectiveness, and communicate progress to...

6 days ago

  •   Less than 5 years exp.  •   Finance & Insurance

$66K - $105K *

Contribute to food safety and quality initiatives by supporting compliance programs, maintaining SQF certification, and collaborating with cross-functional teams to ensure regulatory adherence and con...

3 days ago

  •   5 - 7 years exp.  •   Food & Beverages

$90K - $138K *

Drive excellence in quality assurance by leading a team, ensuring compliance with industry standards, and implementing process improvements for defense contractors. Engage with senior leaders to resol...

2 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$90K - $138K *

Empower a team of quality assurance professionals, ensuring compliance with industry standards and enhancing contractor performance through continuous improvement and technical guidance in a high-stak...

2 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$91K - $139K *

Lead a team of quality assurance professionals, ensuring compliance with industry standards and enhancing contractor performance through continuous improvement initiatives. Collaborate with senior lea...

2 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$94K - $144K *

Take ownership of quality assurance leadership, guiding teams to ensure compliance with industry standards and enhancing contractor performance through continuous improvement initiatives. Engage with...

2 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$108K - $153K *

Innovate packaging solutions by designing and validating complex systems for product launches. Collaborate with cross-functional teams to enhance packaging technologies and ensure compliance with indu...

6 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$89K - $108K *

Join a team that's dedicated to ensuring quality in manufacturing and operations. Oversee compliance with cGMP standards, engage with cross-functional teams, and drive improvements through data analys...

2 weeks ago

  •   Less than 5 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.