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
Locations
caret down
More
1
caret down

$80K - $95K *

Support compliance and quality management systems by leading document control, CAPA investigations, and customer complaint resolutions. Collaborate across departments to enhance quality assurance and...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$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

$210K - $305K *

Lead the global CMC regulatory strategy for a pivotal HCM program, ensuring compliance from Phase 3 through launch and lifecycle management. Drive the development of CMC data packages and regulatory p...

4 days ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$92K - $125K *

Champion regulatory excellence in the lifecycle of innovative IVD products. Collaborate with cross-functional teams to navigate complex regulatory landscapes, ensuring compliance and successful market...

1 week ago

  •   Less than 5 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

$180K - $210K *

Elevate your career by providing strategic regulatory leadership in a dynamic biotechnology environment. Collaborate with cross-functional teams to drive innovative RNA-based therapeutics from develop...

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Drive regulatory compliance by developing strategies for medical products. Collaborate with teams, support submissions, and conduct analyses to mitigate risks throughout product lifecycles in a fast-p...

3 weeks ago

  •   Less than 5 years exp.  •   Business Services

$110K - $130K *

Unlock potential by leading regulatory strategies for medical products, ensuring compliance and guiding projects from inception to market. Collaborate with teams to navigate FDA interactions and suppo...

3 weeks ago

  •   Less than 5 years exp.  •   Business Services

$95K - $115K *

Lead the charge in driving quality and compliance in a fast-paced environment by generating specifications, reviewing procedures, and mentoring teams to ensure regulatory adherence and operational exc...

1 month ago

  •   5 - 7 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

$170K - $231K *

Contribute to regulatory strategy by leading submissions and guiding cross-functional teams. Collaborate with global leads to ensure compliance and timely interactions with health agencies, supporting...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$170K - $231K *

Drive regulatory strategy for early programs, leading cross-functional teams to ensure timely submissions to health agencies. Collaborate with global leads to navigate complex regulatory landscapes an...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$164K - $282K *

Empower innovation by leading regulatory strategies for product launches and compliance. Drive excellence in cross-functional collaboration, ensuring timely approvals and market readiness for orthopae...

Yesterday

  •   8 - 10 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

$90K - $100K *

Join our team to drive regulatory compliance for new products and medical devices. Collaborate with cross-functional teams, manage submissions, and ensure adherence to Health Canada guidelines while s...

Toronto, ONIn-Person

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Optimize compliance by managing regulatory submissions and providing strategic guidance for product development and market expansion across diverse global markets...

4 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$70K - $99K *

Join a team that's dedicated to advancing oncology research by managing regulatory processes for clinical trials. Oversee submissions, mentor staff, and ensure compliance while collaborating with inte...

4 days ago

  •   Less than 5 years exp.  •   Healthcare

$92K - $176K *

Empower innovation by validating laboratory and analytical equipment in a cutting-edge, automated facility. Collaborate with teams to ensure compliance and enhance operational efficiency while mentori...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$90K - $120K *

Lead the charge in regulatory operations, ensuring compliance with global standards and effective communication across teams. Drive submissions, audits, and risk assessments to uphold quality and regu...

3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$185K - $205K *

Collaborate across functions to design regulatory strategies that ensure compliance, support development programs, and facilitate high-quality submissions. Play a pivotal role in navigating complex re...

Reposted 4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$185K - $205K *

Partner with us to drive regulatory compliance strategies that support innovative therapies. Collaborate cross-functionally to ensure timely submissions and adherence to regulations while enhancing op...

Reposted 4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$188K - $240K *

Empower innovation by leading global regulatory strategies for AI-driven medical products. Collaborate with cross-functional teams to ensure compliance and drive successful submissions, while mentorin...

3 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$215K - $253K *

Join a team that's shaping regulatory strategies to ensure timely product approvals and compliance. Collaborate cross-functionally to manage interactions with health authorities and lead regulatory su...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$188K - $240K *

Lead the charge in shaping global regulatory strategies for innovative AI-driven medical products. Collaborate with cross-functional teams to ensure compliance and drive successful submissions, enhanc...

3 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$180K - $210K *

Transform the regulatory landscape by providing strategic leadership in a dynamic biotechnology environment. Collaborate with cross-functional teams to drive innovative RNA-based therapeutic developme...

1 week ago

  •   11 - 15 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.