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.

Remote
caret down
Compensation
caret down
Position Level
caret down
Time Posted
caret down
Industries
caret down
More
1
caret down

$110K - $130K *

Shape the future of health technology by driving regulatory strategies for innovative lab testing, imaging, and AI products. Collaborate with cross-functional teams to ensure compliance and accelerate...

United StatesRemote

Today

  •   5 - 7 years exp.  •   Healthcare

$110K - $130K *

Join a team that's advancing global health by supporting critical clinical trial submissions. In this role, you'll lead regulatory strategies, ensure compliance, and collaborate with diverse teams to...

United StatesRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Drive regulatory intelligence initiatives to ensure compliance and support clinical research. Collaborate with experts to assess regulatory changes, track global guidelines, and enhance impact assessm...

RemoteRemote

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$124K - $170K *

Champion regulatory strategies to accelerate product approvals and compliance. Lead a dynamic team in supporting innovative medical devices, ensuring alignment with global regulations while fostering...

RemoteRemote

4 days ago

  •   5 - 7 years exp.  •   Healthcare

$89K - $119K *

Lead the charge in regulatory compliance by managing global submissions, advising on strategies, and ensuring adherence to standards. Collaborate with cross-functional teams to enhance efficiency and...

Irvine, CARemote

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$82K - $131K *

Engage in regulatory leadership for complex, federally regulated clinical trials. Oversee study start-up, compliance, and mentoring while ensuring adherence to federal regulations and best practices f...

Connecticut, USRemote

Reposted today

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

$83K - $103K *

Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...

United StatesRemote

Reposted 5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Take ownership of regulatory support for pharmaceutical programs, managing IND and NDA submissions, health authority interactions, and lifecycle maintenance. Collaborate with cross-functional teams to...

United StatesRemote

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Transform regulatory strategies for rare disease and cardio-pulmonary drug-device programs. Collaborate with cross-functional teams to ensure compliance and drive successful submissions globally, supp...

United StatesRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$106K - $159K *

Transform regulatory strategies by providing CMC expertise to support product development and compliance in a dynamic pharmaceutical environment, ensuring quality and adherence to global standards thr...

United StatesRemote

1 week ago

  •   5 - 7 years exp.  •   Business Services

$95K - $115K *

Champion regulatory excellence by guiding product development teams, ensuring compliance with global standards, and fostering strong stakeholder relationships to drive business success...

United StatesRemote

3 days ago

  •   5 - 7 years exp.  •   Healthcare

$122K - $143K *

Innovate regulatory operations by managing submission preparation and execution, ensuring compliance with FDA and ICH standards. Collaborate cross-functionally to support complex filings and maintain...

United StatesRemote

Today

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$139K - $184K *

Join a team that's committed to driving innovative regulatory projects, ensuring compliance, and collaborating with cross-functional teams to secure timely submissions and approvals for products in th...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Lead the charge in developing regulatory strategies for medical products, ensuring compliance with FDA standards. Collaborate with teams to navigate the product lifecycle and support submissions for d...

Bethesda, MDRemote

Yesterday

  •   Less than 5 years exp.  •   Business Services

$170K - $195K *

Lead the charge in global regulatory submissions, managing U.S. INDs and ex-U.S. CTAs. Collaborate cross-functionally to develop strategies, ensure compliance, and drive timely approvals in a fast-pac...

San Francisco, CARemote

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$210K - $305K *

Champion the global CMC regulatory strategy for a pivotal HCM program, ensuring compliance from Phase 3 through launch. Collaborate with cross-functional teams to build robust regulatory processes and...

San Francisco, CARemote

4 days ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$180K - $210K *

Drive regulatory strategy and leadership in a dynamic biotech environment, ensuring compliance and advancing innovative RNA-based therapeutics through effective global regulatory submissions and stake...

North Carolina, USRemote

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Champion regulatory strategy initiatives to advance patient treatments. Collaborate with cross-functional teams to develop regulatory pathways, support agency engagement, and ensure compliance, all wh...

RemoteRemote

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$125K - $150K *

Champion global labeling strategy for innovative therapies, leading complex initiatives from development to post-approval. Collaborate with cross-functional teams to ensure compliance and high-quality...

United StatesRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Transform global CMC regulatory strategies for biologics and vaccines, ensuring compliance and quality in submissions. Collaborate with cross-functional teams to influence outcomes and enhance patient...

RemoteRemote

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Empower regulatory excellence by guiding cross-functional teams in compliance and strategy. Leverage deep FDA knowledge to influence promotional materials and ensure adherence to evolving regulations...

United StatesRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$160K - $200K *

Champion regulatory strategy and submissions for clinical-stage radiopharmaceutical programs. Collaborate cross-functionally to ensure compliance and quality in regulatory communications, while leadin...

Cambridge, MARemote

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Transform life science R&D operations by leading initiatives that enhance efficiency and effectiveness across research, clinical, regulatory, and quality domains. Drive change through strategic projec...

United StatesRemote

1 week ago

  •   8 - 10 years exp.  •   Healthcare

$172K - $210K *

Transform regulatory operations by leading submission strategies, managing systems, and ensuring compliance across portfolios while collaborating with cross-functional teams for successful outcomes...

United StatesRemote

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$130K - $160K *

Advance your career by leading regulatory intelligence efforts, analyzing global developments, and providing strategic insights to ensure compliance. Collaborate cross-functionally to enhance processe...

CanadaRemote

3 weeks ago

  •   8 - 10 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.