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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$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

$85K - $100K *

Advance regulatory compliance by managing FDA 510(k) submissions and international documentation. Collaborate with cross-functional teams to ensure product safety and efficacy while maintaining up-to...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$109K - $174K *

Transform the future of healthcare by coordinating regulatory submissions and strategies for innovative medical devices, ensuring compliance and supporting product lifecycle management in a dynamic en...

Today

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$109K - $174K *

Lead the charge in regulatory submissions for medical devices, ensuring compliance with federal and state regulations while collaborating with product development teams to enhance product lifecycle ma...

Today

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$83K - $103K *

Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...

United StatesRemote

Reposted 4 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Shape the future of regulatory affairs by driving compliance and strategic planning for global product registrations. Collaborate cross-functionally to enhance processes and ensure successful submissi...

4 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$100K - $120K *

Lead the charge in ensuring compliance with global regulatory standards, facilitating efficient processes for product registration. Collaborate cross-functionally while managing submissions and develo...

4 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$100K - $120K *

Take ownership of regulatory support for pharmaceutical programs, managing IND and NDA submissions, health authority interactions, and lifecycle maintenance. Collaborate with cross-functional teams to...

United StatesRemote

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$77K - $98K *

Join a team that's dedicated to securing regulatory approvals for innovative medical technologies, ensuring access to life-saving products worldwide while managing multiple submissions and collaborati...

Reposted today

  •   Less than 5 years exp.  •   Healthcare

$145K - $175K *

Join a dynamic team as a Principal Regulatory Affairs Specialist, driving regulatory strategy and compliance for medical devices. Lead submissions, manage registrations, and mentor cross-functional te...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Lead the charge in regulatory strategies for medical devices, guiding global submissions and compliance, while mentoring team members to deliver high-quality regulatory outcomes aligned with best prac...

Reposted 3 days ago

  •   Less than 5 years exp.  •   Healthcare

$89K - $134K *

Accelerate regulatory excellence by guiding product compliance amid dynamic market demands. Collaborate cross-functionally to influence strategy, ensure adherence to regulations, and facilitate succes...

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$108K *

Transform your career by driving regulatory strategies for innovative medical devices. Collaborate with cross-functional teams to ensure compliance and facilitate product approvals while navigating co...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$120K - $145K *

Transform regulatory strategies for rare disease and cardio-pulmonary drug-device programs. Collaborate with cross-functional teams to ensure compliance and drive successful submissions globally, supp...

United StatesRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$86K - $119K *

Join a dynamic team as you ensure regulatory compliance for innovative food brands. Collaborate cross-functionally to navigate North American laws, manage claims, and support product development in a...

Today

  •   Less than 5 years exp.  •   Food & Beverages

$77K - $115K *

Unlock potential by managing regulatory compliance for biocides, overseeing audits and risk management. Collaborate with stakeholders to ensure adherence to EPA regulations and enhance operational eff...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$79K - $169K *

Join a high-performing team to drive compliance and operational readiness in a cutting-edge manufacturing facility. Collaborate across functions to ensure seamless startup and long-term excellence in...

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$117K - $188K *

Elevate your career by managing regulatory activities for combination devices and pharmaceuticals. Leverage your expertise to lead submissions, ensure compliance, and collaborate across teams to drive...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$117K - $188K *

Lead regulatory activities for combination devices and pharmaceuticals, ensuring compliance with FDA and global standards. Collaborate across teams to manage submissions and maintain strong relationsh...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$117K - $188K *

Transform regulatory strategies for combination devices and pharmaceuticals, ensuring compliance with FDA and global standards. Lead complex submissions and collaborate across teams to drive successfu...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$160K - $190K *

Lead the charge in global regulatory strategy for a late-stage immunology program, driving FDA interactions, submissions, and cross-functional decisions while shaping regulatory infrastructure in a dy...

Reposted 4 days ago

  •   Less than 5 years exp.  •   Staffing

$110K - $176K *

Unlock potential by leading global regulatory submissions for medical devices. You will drive strategy, manage compliance risks, and collaborate across teams to navigate complex regulatory landscapes...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$74K - $104K *

Join a dynamic team to enhance global regulatory compliance and market access for life-saving medical products. Collaborate with cross-functional teams to drive process improvements and navigate compl...

6 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Lead the charge in developing regulatory strategies for Canadian projects, ensuring compliance and collaboration across teams to drive successful product development and submissions in a dynamic, scie...

Toronto, ONIn-Person

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.