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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$73K - $132K *

Lead the procurement cycle, negotiate contracts, and collaborate across functions to ensure successful management of federal subcontracts while driving innovation, compliance, and cost-effective solut...

United StatesRemote

Reposted 2 days ago

  •   Less than 5 years exp.  •   Technical Services

$73K - $132K *

Lead the charge in subcontract management and negotiations to drive effective procurement for government programs. Collaborate with cross-functional teams while navigating complex challenges and deliv...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Technical Services

$77K - $118K *

Join our structural design team to lead innovative projects, utilizing 3D modeling software to create structural layouts and solve complex design challenges. Collaborate with multi-disciplinary teams...

United StatesRemote

1 week ago

  •   8 - 10 years exp.  •   Technical Services

$77K - $118K *

Join a team that's shaping the future of clean energy by leading structural design projects. Collaborate with multi-disciplined teams to create innovative solutions, troubleshoot design challenges, an...

2 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$77K - $118K *

Advance your career by leading structural design projects, collaborating within multi-disciplined teams. Utilize 3D modeling tools to develop and troubleshoot structural designs while mentoring junior...

4 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$77K - $118K *

Champion innovative structural design solutions by collaborating with multi-disciplined teams, utilizing 3D modeling tools, and leading design phases to create efficient structural layouts for power p...

4 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$280K - $340K *

Transform regulatory strategy and operations across CMC and clinical activities, leading a high-performing team to ensure compliance and successful product approvals from development through post-appr...

United StatesRemote

3 weeks ago

  •   15+ years exp.  •   Information Technology

$77K - $129K *

Contribute to performance testing of diverse healthcare products by coordinating methodologies and collaborating with design teams to ensure effective test protocols and successful project execution i...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$77K - $129K *

Collaborate with cross-functional teams to drive testing methodologies and ensure quality standards in product development, ensuring timely and accurate performance evaluations to enhance healthcare s...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$313K - $348K *

Lead the charge in shaping global regulatory strategies for innovative gene therapies, ensuring compliance and successful submissions while mentoring a high-performing team in a dynamic environment...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Support engineering execution by leading CAD quality reviews, ensuring process adherence, and facilitating design peer reviews. Collaborate across teams to enhance design integration and operational r...

2 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$69K - $99K *

Analyze and enhance complaint management processes while collaborating with cross-functional teams to ensure timely resolution of product complaints and improve overall quality standards...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Lead the promotional review process, ensuring compliance and strategic guidance for marketing materials across brands. Collaborate with teams to navigate regulatory challenges and enhance promotional...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Innovate clinical study designs for veterinary pharmaceuticals, ensuring safety and efficacy from research to regulatory submission. Lead cross-functional teams and mentor junior scientists while adva...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$269K - $350K *

Innovate regulatory strategies for rare disease development, guiding global compliance from IND through marketing application. Lead teams, drive cross-functional alignment, and engage Health Authoriti...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Empower the development of oral solid drug products while training peers and ensuring compliance with regulatory standards. Contribute to impactful projects that enhance patient outcomes in a collabor...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$85K - $100K *

Join a team that's dedicated to operational excellence and strategic oversight. Lead and mentor a group of permitting professionals, navigating complex challenges while ensuring top-notch service and...

4 weeks ago

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

$110K - $150K *

Lead and develop a regulatory compliance program, ensuring alignment with global standards, managing audits, and driving post-market surveillance initiatives to enhance product safety and efficacy acr...

1 week ago

  •   Less than 5 years exp.  •   Enterprise Technology

$155K - $175K *

Lead the charge in establishing and enhancing a compliant calibration program, ensuring operational excellence in metrology for manufacturing and laboratory systems while collaborating with cross-func...

Today

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$90K - $108K *

Support our Pharmaceutical Development leadership team by providing high-level administrative and project coordination. Your organizational skills will ensure seamless operations in a fast-paced envir...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$68K - $117K *

Partner with us to drive procurement excellence in a dynamic, AI-driven R&D environment. You'll manage the buying desk, streamline processes, and collaborate with teams to ensure efficient vendor onbo...

5 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$90K - $105K *

Unlock your potential as a Senior Scientist I, leading bioassay development and validation projects. Collaborate with clients, mentor team members, and ensure quality in a dynamic lab environment whil...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$76K - $114K *

Empower quality assurance by leading systems and laboratory operations, ensuring compliance and product integrity while driving continuous improvement and safety initiatives across manufacturing proce...

3 weeks ago

  •   Less than 5 years exp.  •   Business Services

$72K - $94K *

Support compliance initiatives by managing quality systems for global sustainability standards such as EU MDR and REACH. Collaborate with internal teams and ensure adherence to regulations while enhan...

Reposted yesterday

  •   Less than 5 years exp.  •   Healthcare

$117K - $184K *

Elevate project execution by leading capital projects from inception to completion. Utilize technical expertise and stakeholder collaboration to ensure safe, compliant, and effective outcomes across d...

Yesterday

  •   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.