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.

Remote
caret down
Compensation
caret down
Position Level
caret down
Time Posted
caret down
Industries
caret down
Locations
caret down
More
1
caret down

$110K - $130K *

Shape the future of health technology by driving regulatory strategies for innovative lab testing, imaging, and AI products. Collaborate with cross-functional teams to ensure compliance and accelerate...

United StatesRemote

Today

  •   5 - 7 years exp.  •   Healthcare

$83K - $138K *

Join a team that's shaping regulatory strategies and ensuring compliance across product lifecycles. Collaborate with cross-functional teams to navigate evolving global regulations and maintain market...

6 days ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Join a team that's advancing global health by supporting critical clinical trial submissions. In this role, you'll lead regulatory strategies, ensure compliance, and collaborate with diverse teams to...

United StatesRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $159K *

Transform regulatory compliance for medical devices by collaborating with cross-functional teams to ensure market access and adherence to evolving regulations throughout the product lifecycle...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$95K - $159K *

Transform regulatory compliance for medical devices by collaborating with cross-functional teams to ensure market access and adherence to evolving regulations throughout the product lifecycle...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$106K - $129K *

Join a team that's shaping the future of medical devices by driving regulatory strategies and submissions globally. Leverage your expertise to ensure compliance and support innovative product developm...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$106K - $129K *

Champion regulatory excellence by leading submissions and strategies for medical devices, ensuring compliance with global standards while driving innovation in product development and post-market acti...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Engage in international regulatory affairs, driving submissions, registrations, and lifecycle management for medical devices in the UK, Japan, and Latin America. Collaborate with regulatory bodies and...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Drive regulatory intelligence initiatives to ensure compliance and support clinical research. Collaborate with experts to assess regulatory changes, track global guidelines, and enhance impact assessm...

RemoteRemote

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$124K - $170K *

Champion regulatory strategies to accelerate product approvals and compliance. Lead a dynamic team in supporting innovative medical devices, ensuring alignment with global regulations while fostering...

RemoteRemote

4 days ago

  •   5 - 7 years exp.  •   Healthcare

$95K - $115K *

Champion innovation by leading regulatory submissions for medical devices globally. Ensure compliance with FDA and international standards while collaborating with cross-functional teams to drive prod...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$85K - $100K *

Join a dynamic team to drive regulatory strategies for innovative medical devices. Collaborate with cross-functional teams, ensuring compliance and successful submissions in the U.S. and international...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$129K - $207K *

Champion regulatory excellence by leading submissions for medical devices globally. Collaborate with cross-functional teams to ensure compliance and support product lifecycle management while navigati...

3 days ago

  •   5 - 7 years exp.  •   Healthcare

$89K - $119K *

Shape the future of regulatory compliance by leading global submissions and strategies. Collaborate with cross-functional teams to ensure adherence to regulations while driving process improvements an...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$89K - $119K *

Lead the charge in regulatory compliance by managing global submissions, advising on strategies, and ensuring adherence to standards. Collaborate with cross-functional teams to enhance efficiency and...

Irvine, CARemote

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$95K - $115K *

Join a team that's shaping the future of medical devices and digital health. As a Regulatory Affairs Specialist, you'll drive regulatory strategies for innovative technologies, ensuring compliance and...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$80K - $95K *

Optimize global regulatory compliance by managing submissions, audits, and documentation. Collaborate on EU MDR projects and ensure alignment with standards while supporting product registrations and...

Cambridge, ONIn-Person

3 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$91K - $137K *

Join a team that's dedicated to ensuring regulatory compliance for medical devices. Lead initiatives for domestic and international registrations while collaborating with marketing and development tea...

4 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$101K - $152K *

Execute regulatory strategies for global product approvals, guiding teams through the lifecycle and managing submissions. Foster agency relationships, maintain compliance, and lead audits while mentor...

Reposted 4 days ago

  •   5 - 7 years exp.  •   Healthcare

$110K - $183K *

Join a dynamic team as you drive regulatory activities across product development and lifecycle management, ensuring compliance and market access while collaborating with cross-functional teams in a f...

Reposted 6 days ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $183K *

Transform regulatory processes by guiding compliance across product development and lifecycle management. Collaborate with cross-functional teams to ensure market access and navigate evolving regulato...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$165K - $175K *

Join a dynamic team to drive regulatory submissions for oncology products. Collaborate across functions to ensure compliance and strategic planning, while managing timelines and enhancing regulatory p...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$175K - $200K *

Join a dynamic team to manage regulatory submissions for oncology products, ensuring compliance and strategic guidance across cross-functional collaborations. Drive high-quality submissions and contri...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$82K - $131K *

Engage in regulatory leadership for complex, federally regulated clinical trials. Oversee study start-up, compliance, and mentoring while ensuring adherence to federal regulations and best practices f...

Connecticut, USRemote

Reposted today

  •   5 - 7 years exp.  •   Education, Government & Non-Profit

$92K - $138K *

Drive regulatory data governance and process excellence across multiple product portfolios. Collaborate with cross-functional teams to enhance data quality, ensure compliance, and support digital tran...

3 days ago

  •   Less than 5 years exp.  •   Healthcare

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.