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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$177K - $221K *

Champion regulatory excellence by leading cross-functional teams, ensuring compliance, and driving successful oncology drug development through strategic planning and expert guidance...

United StatesRemote

3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Elevate regulatory standards by serving as a senior SME for military-focused drugs and medical devices. Lead the development of submission strategies and mentor cross-functional teams in compliance pr...

3 weeks ago

  •   Less than 5 years exp.  •   Business Services

$94K - $174K *

Lead quality assurance initiatives to ensure compliance and operational excellence in sterile drug manufacturing. Collaborate cross-functionally to embed quality standards and drive continuous improve...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$130K - $150K *

Join a team that's dedicated to ensuring compliance and quality in laboratory digital systems. Oversee the lifecycle management of LIMS and analytical platforms, translating business needs into compli...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$128K - $210K *

Manage regulatory activities for advertising and promotion, ensuring compliance while collaborating with cross-functional teams to develop impactful product messaging and materials that align with com...

United StatesRemote

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$89K - $134K *

Elevate quality assurance processes by leading investigations, ensuring compliance with FDA and international regulations, and driving corrective actions. Collaborate with stakeholders to enhance qual...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$89K - $134K *

Elevate your career by driving quality compliance and oversight in a dynamic environment. Collaborate with stakeholders to implement effective quality systems and ensure adherence to regulatory standa...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$110K - $130K *

Lead the charge in ensuring design quality and compliance for Class II/III medical devices. Collaborate with cross-functional teams to drive adherence to design controls, risk management, and SDLC bes...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$90K - $115K *

Unlock potential by driving quality risk management and compliance initiatives. Collaborate with cross-functional teams to assess and mitigate risks, ensuring patient safety and product quality in a r...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$145K - $160K *

Lead the charge in developing and managing equipment qualification and validation strategies for cGMP manufacturing and QC labs, ensuring compliance with regulatory standards and delivering high-quali...

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Elevate your career by leading radiopharmaceutical manufacturing processes. As a Senior Specialist, you'll ensure compliance, mentor new staff, and drive operational excellence in a dynamic production...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$82K - $115K *

Drive compliance and quality in R&D by overseeing documentation, audits, and inspections. Collaborate with teams to ensure adherence to cGMP standards and enhance quality systems, supporting regulator...

Today

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$82K - $115K *

Join a team that's dedicated to ensuring R&D compliance and quality. Leverage your expertise in quality systems, documentation, and regulatory guidance to support R&D functions and drive continuous im...

4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$152K - $196K *

Transform compliance and quality in regulatory affairs by leading strategic operations, ensuring timely approvals, and optimizing submission processes for medical devices and pharmaceuticals across gl...

Reposted 2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$195K - $244K *

Unlock your potential as a Global Regulatory Leader, driving regulatory strategy and submissions for CNS projects. Collaborate with cross-functional teams, mentor junior staff, and ensure compliance w...

United StatesRemote

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Elevate regulatory project management by leading cross-functional teams to ensure timely execution of complex pharmaceutical and medical device initiatives, aligning with global regulatory standards a...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$149K - $166K *

Lead the charge in regulatory operations, ensuring timely, high-quality submissions to global health authorities. Collaborate with cross-functional teams to manage project timelines, risks, and compli...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$102K - $177K *

Shape the future of pharmacovigilance by leading compliance oversight for ICSR reporting. Collaborate with cross-functional teams to identify risks, drive improvements, and ensure adherence to regulat...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$102K - $177K *

Transform compliance oversight in pharmacovigilance by leading ICSR reporting initiatives, driving continuous improvement, and fostering cross-functional partnerships to ensure regulatory adherence an...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$102K - $177K *

Lead the charge in ensuring compliance for ICSR reporting, driving risk management and continuous improvement. Collaborate with cross-functional teams to enhance pharmacovigilance practices and foster...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$85K - $110K *

Shape regulatory compliance strategies by collaborating with teams to interpret global standards, generate key documentation, and support product evaluation in a dynamic environment, ensuring safety a...

3 weeks ago

  •   Less than 5 years exp.  •   Food & Beverages

$81K - $112K *

Champion compliance and innovation in sterility assurance, collaborating cross-functionally to support regulatory mandates and ensure product safety and efficacy through sterilization processes in man...

4 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$150K - $180K *

Deliver strategic regulatory leadership for global development programs, overseeing regulatory strategy and execution from late-stage clinical phases to marketing authorization while ensuring complian...

North Carolina, USRemote

Reposted 4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Take ownership of environmental compliance initiatives by developing water quality plans, leading fieldwork, and analyzing data to ensure regulatory adherence and support project management efforts in...

1 week ago

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

$80K - $95K *

Oversee regulatory compliance for chemical products, ensuring adherence to TSCA and federal/state regulations. Collaborate with cross-functional teams to provide guidance, manage submissions, and main...

3 days ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

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.