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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$170K - $200K *

Lead cross-functional integration of data, analytics, evaluation, and governance to enhance healthcare AI products. Drive roadmap ownership, optimize workflows, ensure data quality, and foster collabo...

Palo Alto, CARemote

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$134K - $205K *

Transform the future of clean energy by innovating nuclear power plant systems design, leading engineering projects, and collaborating on modifications that enhance operational efficiency and safety...

3 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$134K - $205K *

Play a key role in nuclear power systems design, overseeing modifications, analyses, and technical documentation. Lead engineering project teams and interface with clients to enhance operational effic...

4 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$134K - $205K *

Optimize nuclear power plant systems design by preparing and reviewing modification packages, engineering analyses, and technical specifications while leading project teams and interfacing with client...

4 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$134K - $205K *

Lead the charge in engineering design for nuclear power plants, overseeing modifications, evaluations, and vendor assessments. Collaborate closely with teams and clients to enhance systems and ensure...

4 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$134K - $205K *

Transform the nuclear power sector by engaging in design, modification, and evaluation of plant systems. Collaborate with clients and lead project teams while leveraging engineering expertise to deliv...

4 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$134K - $205K *

Join a dynamic team influencing nuclear power systems design. Contribute to modification packages, technical specifications, and engineering analyses to enhance operations and lead projects, ensuring...

United StatesRemote

1 month ago

  •   11 - 15 years exp.  •   Technical Services

$193K - $227K *

Join us in enhancing our Sarbanes-Oxley compliance program by managing internal controls, collaborating with cross-functional teams, and leading remediation efforts to ensure a robust risk-based contr...

5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Shape the future of quality assurance by leading audits and enhancing compliance. Collaborate with cross-functional teams to identify risks, resolve issues, and drive continuous improvement in our Qua...

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Join a team that's shaping the future of torpedo test equipment. As a Senior Mechanical Engineer, you'll lead high-profile projects, collaborate with diverse teams, and drive innovation from concept t...

2 weeks ago

  •   Less than 5 years exp.  •   Information Technology

$80K - $95K *

Transform compliance training by managing our Learning Management System (LMS). Lead innovative training initiatives, ensure regulatory adherence, and optimize documentation processes to support effec...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Grow your career with a dynamic team focused on cyber risk management, vulnerability assessment, and compliance. Leverage your expertise to enhance security operations for state and local government c...

5 days ago

  •   5 - 7 years exp.  •   Information Technology

$95K - $115K *

Shape the future of product safety by leading compliance efforts, mentoring engineers, and ensuring regulatory standards are met throughout the product lifecycle. Collaborate with cross-functional tea...

Yesterday

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$100K - $120K *

Elevate patient recruitment strategies across clinical trials. Lead global initiatives, optimize engagement, and ensure compliance through innovative solutions and effective collaboration. Drive enrol...

RemoteRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$79K - $150K *

Elevate billing processes by overseeing design and governance within Oracle, ensuring efficiency and accuracy in invoicing. Collaborate with cross-functional teams to drive improvements and mentor jun...

United StatesRemote

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$80K - $95K *

Unlock potential by serving as a subject matter expert, providing specialized training and support for medical devices in clinical settings. Collaborate with healthcare professionals to enhance produc...

Vaughan, ONIn-Person

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$186K - $279K *

Unlock potential by providing strategic regulatory leadership for product development and lifecycle management. Collaborate across teams to ensure compliance and influence regulatory outcomes in a dyn...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$81K - $150K *

Advance calibration excellence by leading complex troubleshooting, mentoring staff, and establishing robust calibration and metrology programs in a dynamic manufacturing environment. Collaborate acros...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Drive the development and validation of analytical methods for drug formulation. Manage projects in a GMP laboratory, support stability testing, mentor junior scientists, and collaborate with cross-fu...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$125K - $150K *

Join a team that's shaping the future of regulatory affairs and public policy. Drive strategic engagement, advocate for key investments, and navigate the evolving landscape to protect and expand our p...

1 week ago

  •   5 - 7 years exp.  •   Enterprise Technology

$125K - $150K *

Join a dynamic team to shape regulatory strategies and public policy initiatives, ensuring a favorable landscape for operations. Collaborate with stakeholders to protect investments and drive impactfu...

1 week ago

  •   5 - 7 years exp.  •   Enterprise Technology

$95K - $115K *

Join us in enhancing supplier quality for critical sensor projects. Collaborate with cross-functional teams to ensure compliance with quality standards, drive supplier performance, and support manufac...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$95K - $115K *

Drive supplier quality excellence by managing audits, improving KPIs, and ensuring compliance with industry standards. Collaborate across teams to enhance manufacturability and support supplier develo...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$95K - $115K *

Optimize supplier quality processes and drive continuous improvement initiatives. Collaborate with cross-functional teams to enhance product performance and ensure compliance with quality standards, c...

3 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$95K - $115K *

Transform proposal development by collaborating with diverse teams to manage logistics, maintain configuration control, and ensure timely delivery of high-quality proposals for federal government oppo...

1 week ago

  •   5 - 7 years exp.  •   Real Estate & Construction

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.