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 - $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

$120K - $181K *

Lead regulatory strategies to ensure global product compliance and approval. Collaborate with cross-functional teams to drive successful submissions and maintain regulatory standards, while fostering...

2 days ago

  •   5 - 7 years exp.  •   Healthcare

$120K - $181K *

Manage regulatory strategies for global product approvals, ensuring compliance and collaboration across teams. Lead submission activities for medical devices, fostering a high-performance culture whil...

2 days ago

  •   5 - 7 years exp.  •   Healthcare

$92K - $148K *

Join a dynamic team to develop and execute global regulatory strategies for innovative medical devices, ensuring compliance and supporting product development in a fast-paced environment focused on im...

Raritan, NJRemote

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$119K - $133K *

Join a team that's dedicated to advanced regulatory problem-solving in nuclear operations. Leverage your expertise to manage regulatory analyses, ensure compliance, and drive improvements in performan...

3 weeks ago

  •   Less than 5 years exp.  •   Energy & Utilities

$119K - $133K *

Transform the future of nuclear operations by providing advanced regulatory expertise, managing compliance, and driving innovative solutions to enhance plant performance and safety. Engage with cross...

3 weeks ago

  •   5 - 7 years exp.  •   Energy & Utilities

$145K - $168K *

Champion regulatory excellence by ensuring compliance in labeling and documentation. Collaborate with cross-functional teams to create clear, accurate Instructions for Use (IFU) and marketing material...

4 days ago

  •   5 - 7 years exp.  •   Healthcare

$145K - $168K *

Transform regulatory compliance by authoring and maintaining labeling documents, collaborating with cross-functional teams, and ensuring adherence to industry standards for global product lifecycle ma...

4 days ago

  •   5 - 7 years exp.  •   Healthcare

$82K - $118K *

Champion quality excellence by managing supplier compliance and quality systems. Collaborate with cross-functional teams to ensure adherence to regulatory standards, drive continuous improvement, and...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$177K - $221K *

Lead the development and execution of global CMC regulatory strategies to support clinical trials and market applications, ensuring compliance with regulatory requirements throughout the product lifec...

United StatesRemote

2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Partner with us to drive regulatory compliance excellence in the medical device sector. Support CAPA initiatives, enhance the Quality Management System, and collaborate across teams to ensure adherenc...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$175K - $220K *

Lead regulatory strategy and execution for IVD products, ensuring compliance and successful submissions. Collaborate across teams to shape development plans and manage regulatory risks, driving projec...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$244K - $305K *

Lead the charge in building and optimizing regulatory information management capabilities, focusing on Veeva Vault RIM. Collaborate across functions to enhance global processes and ensure compliance w...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$101K - $197K *

Empower your career by leading global regulatory strategies for medical devices and diagnostics. Collaborate with cross-functional teams to ensure compliance and drive market access while mentoring ot...

United StatesRemote

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$172K - $275K *

Lead the execution of global regulatory strategies and ensure compliance, acting as a strategic partner across teams. Develop a high-performing regulatory team, simplify processes, and drive operation...

Reposted 3 weeks ago

  •   11 - 15 years exp.  •   Healthcare

$200K - $260K *

Join a team that's shaping regulatory compliance strategies in the pharmaceutical sector. Lead cross-functional initiatives, drive compliance risk management, and ensure inspection readiness while men...

2 weeks ago

  •   11 - 15 years exp.  •   Food & Beverages

$110K - $130K *

Contribute to regulatory strategies for military-relevant drugs, biologics, and medical devices. Mentor teams, prepare submissions, and engage with FDA and other agencies to ensure compliance and opti...

Today

  •   Less than 5 years exp.  •   Business Services

$250K - $285K *

Advance global regulatory strategies for late-stage programs, ensuring compliance and successful submissions. Collaborate across functions to mitigate risks and drive major filings, representing the o...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$108K - $176K *

Unlock potential by leading CMC regulatory strategies for biologics, ensuring compliance and collaboration across development and post-market programs to drive impactful patient outcomes in a dynamic...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$108K - $176K *

Lead regulatory strategy and compliance for biologics, driving CMC initiatives across development and submissions while collaborating with global teams to ensure alignment and efficiency in a dynamic...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$108K - $176K *

Join us to lead CMC regulatory strategies for biologics, ensuring compliance and collaboration across development and submissions. Drive impactful regulatory activities in a dynamic, science-driven en...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$148K - $170K *

Lead the charge in regulatory strategy for advertising and promotion across therapeutic areas, ensuring compliance while driving business objectives. Collaborate with cross-functional teams to navigat...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$119K - $140K *

Drive regulatory excellence in medical devices and biologics, ensuring compliance and strategic submissions to FDA and international bodies. Collaborate across teams to support product development and...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$172K - $275K *

Join a team that's defining global regulatory strategies to enable compliant growth and market access. Leverage your leadership skills to mentor a diverse team and drive best practices across regions...

3 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$90K - $150K *

Join a team that's at the forefront of IVD product compliance and regulatory excellence. Utilize your expertise in 510(k) submissions and navigate the complexities of FDA regulations to drive successf...

1 month 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.