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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1
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$117K - $184K *

Join a dynamic team to lead vaccine technology transfers, ensuring compliance and efficiency. Drive cross-functional projects, mentor new talent, and enhance process robustness in a fast-paced biophar...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Manage a regulatory team to ensure compliance with FDA and Health Canada standards. Drive regulatory strategy for product innovation and oversee compliance assessments, while collaborating with cross...

3 weeks ago

  •   11 - 15 years exp.  •   Food & Beverages

$110K - $130K *

Empower product compliance and approvals by overseeing regulatory submissions, collaborating with teams, and delivering insights on regulations for medical devices through their lifecycle. Your expert...

4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Lead impactful quality systems and compliance initiatives, overseeing deviation, CAPA, and complaints management. Collaborate across functions to enhance quality performance and drive continuous impro...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $150K *

Shape quality excellence and compliance by leading regulatory strategies, fostering team growth, and ensuring robust quality management systems in alignment with industry standards and corporate goals...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$181K - $224K *

Elevate global CMC regulatory strategies for commercial compounds. Collaborate cross-functionally to ensure compliance and timely submissions, while leading projects and maintaining expertise in regul...

Carlsbad, CARemote

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$181K - $224K *

Lead the charge in developing global CMC regulatory strategies for commercial compounds, ensuring compliance and timely submissions across multiple regions while collaborating with cross-functional te...

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Champion the integrity of IT Validation & Compliance within a CDMO, ensuring adherence to cGMPs and regulatory standards by overseeing enterprise software validation and reviewing critical quality del...

North Carolina, USRemote

4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Drive regulatory strategy for US and Canada, ensuring compliance and effective communication with health authorities. Collaborate cross-functionally to support product commercialization and navigate c...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$130K - $155K *

Lead the development and execution of regulatory strategies for US and Canada, ensuring compliance and effective communication with health authorities. Collaborate cross-functionally to support produc...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Elevate your career by leading regulatory strategies for US and Canada markets. Drive compliance and innovation for on-market and developing products while collaborating with cross-functional teams to...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $90K *

Unlock potential by ensuring compliant cell therapy manufacturing through effective deviation investigations, CAPA implementation, and continuous improvement initiatives while collaborating with Quali...

6 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$97K - $130K *

Join a dynamic team as you empower our medical devices to achieve compliance and excellence post-commercialization, driving quality, safety, and performance improvements through rigorous data analysis...

1 month ago

  •   5 - 7 years exp.  •   Healthcare

$146K - $182K *

Transform regulatory strategies in FDA Pharma and IVDR, ensuring compliance and driving product approvals. Collaborate with cross-functional teams, mentor associates, and enhance processes to support...

United StatesRemote

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$85K - $100K *

Elevate clinical research effectiveness by leading monitoring visits, ensuring the highest quality standards across diverse therapeutic areas, and facilitating communication between sites and internal...

Vancouver, BCIn-Person

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Advance your career by leading clinical research projects and ensuring compliance with timelines and standards. Collaborate with stakeholders and clinical sites to safeguard subjects' rights and data...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$92K - $148K *

Elevate patient care by developing global regulatory strategies for innovative medical devices. Collaborate with cross-functional teams to ensure compliance and support product lifecycle management in...

6 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$153K - $268K *

Champion the regulatory strategy for starting materials in drug manufacturing, ensuring compliance with ICH Q11 and regional guidelines. Collaborate cross-functionally to support late-stage clinical a...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$78K - $108K *

Empower your career by driving regulatory compliance and documentation excellence in product development. Collaborate across teams to ensure high-quality formulation management for OTC drugs, dietary...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Champion regulatory strategies and stakeholder relationships to enhance business objectives. Collaborate across teams to navigate complex regulatory landscapes, ensuring compliance and effective commu...

1 week ago

  •   8 - 10 years exp.  •   Energy & Utilities

$150K - $190K *

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...

United StatesRemote

Reposted 3 days ago

  •   11 - 15 years exp.  •   Information Technology

$95K - $115K *

Unlock the potential of quality control by conducting critical testing and validation. Collaborate with a dynamic team to ensure compliance with regulatory standards while driving continuous improveme...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join a team that's dedicated to ensuring regulatory compliance in a complex pharmaceutical manufacturing environment. Collaborate globally to support quality assurance and maintain adherence to health...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$92K - $148K *

Advance your career in regulatory affairs through a dynamic fellowship program. Collaborate with experts, tackle real-world projects, and gain invaluable insights into drug development while enhancing...

Today

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$92K - $148K *

Empower your career in regulatory affairs through a dynamic fellowship, gaining hands-on experience across diverse therapeutic areas while collaborating with industry leaders to influence drug develop...

Today

  •   Less than 5 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.