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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$80K - $95K *

Lead regulatory compliance for clinical research, ensuring adherence to federal and state regulations. Collaborate with diverse teams to streamline workflows, support timely study activation, and prom...

2 days ago

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

$86K - $125K *

Join a team that's dedicated to enhancing aerospace quality systems, ensuring compliance with industry standards, and driving continuous improvement in a silicone manufacturing environment. Lead quali...

1 week ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$109K - $179K *

Launch impactful analyses by leveraging diverse biomarker data and computational tools to drive insights for Precision Medicine projects. Collaborate across studies to optimize data quality and visual...

Reposted 4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$109K - $179K *

Unlock potential by leveraging your computational expertise to analyze and visualize complex biomarker data, driving innovative insights in Precision Medicine. Collaborate closely with teams to ensure...

Reposted 4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Elevate product quality by establishing standards, supervising teams, and ensuring compliance with testing procedures. Drive continuous improvement initiatives while maintaining documentation and achi...

1 week ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$80K - $95K *

Drive quality assurance initiatives by developing processes and standards to ensure product excellence. Collaborate with cross-functional teams to identify risks, conduct audits, and implement correct...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$88K - $105K *

Take ownership of engineering documentation for advanced radar systems. Collaborate with multidisciplinary teams to develop and maintain technical drawings, ensuring compliance with standards while su...

2 days ago

  •   Less than 5 years exp.  •   Real Estate & Construction

$120K - $145K *

Champion regulatory policy initiatives by analyzing market developments and influencing key energy regulations. Collaborate with teams to drive strategic recommendations and enhance project competitiv...

1 week ago

  •   5 - 7 years exp.  •   Energy & Utilities

$120K - $150K *

Join our dynamic Regulatory Affairs team to drive compliance and strategy for product launches across multiple markets. Collaborate cross-functionally to ensure regulatory adherence and support innova...

2 weeks ago

  •   Less than 5 years exp.  •   Retail & Consumer Goods

$140K - $155K *

Join a team that's dedicated to enhancing manufacturing and quality engineering processes. You'll provide critical support for classified programs, ensuring production efficiency and quality standards...

3 days ago

  •   Less than 5 years exp.  •   Information Technology

$134K - $219K *

Empower global clinical trial success by leading risk-based monitoring strategies. Collaborate with cross-functional teams to enhance site management, ensure compliance, and drive operational excellen...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$134K - $219K *

Lead the charge in developing risk-based monitoring strategies for global clinical trials, ensuring high-quality site management and operational excellence while collaborating with cross-functional te...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$134K - $219K *

Shape the future of global clinical trials by leading risk-based monitoring strategies, ensuring high-quality site management, and driving operational excellence across diverse studies in a collaborat...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Lead quality oversight for drug manufacturing, ensuring compliance with cGMPs. Collaborate with vendors on batch record review and product disposition for global clinical programs, thriving in a dynam...

United StatesRemote

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join a dynamic team as a Senior Public Affairs Specialist, supporting strategic communication efforts within the Air Force. Leverage your expertise in media analysis and public relations to enhance or...

4 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$105K - $168K *

Join a team that's dedicated to advancing healthcare through innovative solutions. Leverage your expertise in communication, technical writing, and regulatory knowledge to drive impactful projects in...

Yesterday

  •   Less than 5 years exp.  •   Healthcare

$95K - $115K *

Lead logistics management functions for ship acquisition programs, ensuring effective planning, resource utilization, and compliance with DOD policies. Collaborate across teams to enhance operational...

Yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$95K - $115K *

Unlock your potential as you support logistics management for large amphibious ships, ensuring effective planning, resource utilization, and lifecycle support in a dynamic environment focused on shipb...

Yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$167K - $282K *

Lead the charge in shaping global EHS3 strategy, ensuring compliance and operational excellence across diverse functions while driving transformational initiatives and enterprise governance frameworks...

United StatesRemote

Reposted yesterday

  •   11 - 15 years exp.  •   Business Services

$110K - $130K *

Take ownership of complex validation projects, providing technical leadership and ensuring compliance for GMP manufacturing and R&D initiatives in a regulated environment. Drive continuous improvement...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $155K *

Contribute to the design and development of electronic hardware for medical devices, driving complex technical solutions and collaborating with cross-functional teams throughout the product lifecycle...

3 weeks ago

  •   5 - 7 years exp.  •   Business Services

$90K - $110K *

Champion quality excellence by overseeing and implementing robust QA/QC systems, ensuring compliance with federal standards and project specifications while collaborating with diverse stakeholders thr...

5 days ago

  •   8 - 10 years exp.  •   Energy & Utilities

$119K - $221K *

Engage with key accounts to drive sales of advanced Mass Spectrometry solutions. Utilize your expertise to implement growth strategies, nurture customer relationships, and coordinate efforts to achiev...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$173K - $272K *

Drive global product compliance and sustainability strategies across diverse technology solutions. Lead cross-functional teams to ensure regulatory adherence throughout the product lifecycle, fosterin...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$135K - $145K *

Transform manufacturing quality processes by leading risk management and continuous improvement initiatives, ensuring compliance and excellence in medical device production while mentoring teams and d...

1 week ago

  •   5 - 7 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.