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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$130K - $160K *

Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...

United StatesRemote

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$211K - $281K *

Champion regulatory excellence by leading U.S. FDA engagement and strategy for product development, ensuring timely approvals and compliance while driving cross-functional collaboration and organizati...

United StatesRemote

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$222K - $303K *

Optimize regulatory strategies for product development and submissions. Lead cross-functional teams, manage FDA communications, and ensure compliance with global regulations. Drive innovation in regul...

New Jersey, USRemote

Today

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$67K - $115K *

Empower project success by delivering expert regulatory submissions and compliance. Collaborate with cross-functional teams to ensure adherence to country-specific regulations, timelines, and quality...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$75K - $101K *

Advance regulatory compliance and product stewardship for diverse filtration and life sciences products, ensuring safety and sustainability while supporting innovation and business growth across globa...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$75K - $101K *

Champion regulatory compliance and product stewardship for diverse filtration and life sciences products, ensuring safety and sustainability while driving business growth and innovation across global...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$119K - $154K *

Lead the charge in regulatory operations, ensuring compliance and quality for medical devices. Oversee documentation systems, manage global submissions, and guide teams to achieve project goals while...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$122K - $176K *

Lead regulatory strategies for advertising and promotion in the pharmaceutical sector. Collaborate with cross-functional teams to address complex issues, ensuring compliance and maximizing product imp...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$122K - $176K *

Drive regulatory strategies for advertising and promotion, collaborating with cross-functional teams to ensure compliance and maximize product impact. Oversee projects with minimal supervision while p...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$119K - $154K *

Transform regulatory operations by leading teams to ensure compliance and quality in medical device submissions. Oversee projects, manage documentation systems, and drive continuous improvement to mee...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$145K - $175K *

Champion regulatory strategy for innovative digital health products, leading a team to ensure compliance and market readiness. Collaborate across functions to navigate complex regulations and drive su...

5 days ago

  •   8 - 10 years exp.  •   Healthcare

$137K - $220K *

Elevate your career by driving global regulatory strategies and practices. Collaborate with cross-functional teams to ensure compliance and efficiency in labeling and registration processes, while lev...

Yesterday

  •   8 - 10 years exp.  •   Healthcare

$125K - $150K *

Join a dynamic team and take ownership of regulatory activities for various pharmaceutical products, providing guidance and ensuring compliance while collaborating with cross-functional teams across N...

Reposted 3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$104K - $130K *

Help us ensure compliance with export regulations while collaborating across teams to implement effective processes. This role is vital in supporting trade compliance and managing risk in a dynamic ae...

Today

  •   5 - 7 years exp.  •   Aerospace & Defense

$170K - $231K *

Transform your career by leading global CMC regulatory strategies for innovative therapeutics. Collaborate across teams to navigate complex regulatory landscapes and drive the development of cutting-e...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$170K - $231K *

Strategize global CMC regulatory approaches for innovative therapeutics, bridging research and development. Lead regulatory submissions and guide teams through evolving landscapes, ensuring compliance...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$78K - $110K *

Empower your career by providing advanced paralegal services in regulatory compliance. Collaborate with attorneys and clients on complex legal matters, ensuring timely filings and maintaining essentia...

3 weeks ago

  •   8 - 10 years exp.  •   Finance & Insurance

$78K - $110K *

Drive impactful paralegal services for regulatory compliance and legal matters. Collaborate with attorneys and clients to ensure timely filings, maintain records, and support complex projects while me...

3 weeks ago

  •   8 - 10 years exp.  •   Finance & Insurance

$100K - $120K *

Empower medical device compliance by reviewing and submitting regulatory documentation. Collaborate across teams to secure timely approvals while ensuring adherence to FDA, ISO 13485, and global stand...

4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$87K - $131K *

Optimize global regulatory activities for medical devices, ensuring compliance in labeling, UDI, and product data. Collaborate with cross-functional teams to support product registrations and maintain...

Massachusetts, USRemote

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$95K - $133K *

Lead the New Product Development (NPD) submission process, ensuring strategic alignment and risk mitigation. Collaborate with internal teams and partners to optimize regulatory submissions and respons...

Toronto, ONIn-Person

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $133K *

Accelerate progress at the forefront of New Product Development by leading regulatory submissions, ensuring compliance, and collaborating with internal and external teams to drive successful product l...

North York, ONIn-Person

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $100K *

Join a team that's dedicated to advancing global market access for medical devices. Leverage your regulatory expertise to support product registrations and ensure compliance while collaborating with c...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$140K - $170K *

Manage regulatory program support by coordinating submissions, ensuring compliance, and driving operational excellence across cross-functional teams. Collaborate with global leads to deliver high-qual...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$135K - $183K *

Drive compliance excellence by leading the development and oversight of regulatory frameworks across diverse functions, ensuring alignment with global standards and fostering continuous improvement th...

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.