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

$164K - $282K *

Lead the charge in shaping global regulatory strategies for innovative orthopaedic products. Drive excellence in product launches and portfolio management while mentoring a talented team to ensure com...

Reposted yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$164K - $282K *

Transform your career by leading regulatory strategies for innovative orthopaedic products. Collaborate with cross-functional teams to ensure timely product launches and compliance with global regulat...

Reposted yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$164K - $282K *

Shape the future of regulatory strategy by leading cross-functional teams to ensure timely product commercialization and compliance with global regulations, while developing future leaders in the Regu...

Reposted yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$85K - $142K *

Lead the charge in ensuring product excellence by collaborating with R&D and cross-functional teams to drive quality standards in new product development for surgical devices, enhancing patient safety...

Reposted 2 days ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Lead the charge in evaluating complex materials engineering issues, ensuring compliance with NRC regulations. Utilize your expertise to support inspections, develop guidance, and mentor junior staff w...

1 week ago

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

$150K - $180K *

Oversee global Regulatory Affairs Study Start-Up operations, ensuring performance, quality, and compliance. Lead a diverse team, manage budgets, and drive strategic initiatives to meet corporate objec...

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$150K - $180K *

Lead the charge in global Regulatory Affairs Study Start-Up, ensuring operational excellence, financial performance, and compliance. Drive team development and strategic initiatives across a large, di...

2 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$109K - $273K *

Join us as a Senior Epidemiologist to independently drive real-world evidence initiatives in oncology, focusing on ovarian and lung cancer. Collaborate closely with a dedicated sponsor to enhance earl...

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join us to lead utility rebate and incentive efforts for geothermal heating. Collaborate with our Policy team to shape regulatory strategies and build relationships with key stakeholders across multip...

3 weeks ago

  •   Less than 5 years exp.  •   Energy & Utilities

$80K - $95K *

Discover an opportunity to empower energy policy initiatives and drive utility incentives. Join our dynamic team to shape regulatory strategies for geothermal heating, building relationships with stak...

3 weeks ago

  •   Less than 5 years exp.  •   Energy & Utilities

$80K - $95K *

Engage with cross-functional teams to ensure product compliance with global EMC/RF/Product Safety standards. Oversee testing processes, manage certification schedules, and provide expert guidance to m...

2 weeks ago

  •   Less than 5 years exp.  •   Telecommunications & Hardware

$120K - $150K *

Join a dynamic Regulatory Affairs team to drive compliance and strategy for product launches across multiple markets. Collaborate cross-functionally to ensure regulatory adherence and support lifecycl...

2 weeks ago

  •   Less than 5 years exp.  •   Retail & Consumer Goods

$80K - $95K *

Help us ensure quality excellence across multiple programs by providing vital QA support, managing product releases, and guiding teams through GMP compliance. Collaborate effectively in a dynamic envi...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$109K - $174K *

Lead the development of innovative surgical navigation systems in orthopaedics. Collaborate with cross-functional teams to define requirements, conduct risk analysis, and ensure system reliability for...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Elevate quality and compliance as you lead validation strategies across cross-functional teams, ensuring robust testing and regulatory adherence in a dynamic GMP environment. Drive innovation and oper...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$82K - $105K *

Champion quality assurance by overseeing product inspections and compliance. Lead initiatives to establish quality standards, mentor teams, and drive continuous improvement in manufacturing processes...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$90K - $112K *

Champion the advancement of quality systems and technical expertise in collaboration with cross-department teams, driving continuous improvement initiatives and ensuring compliance in laboratory opera...

3 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$93K - $153K *

Elevate clinical trial success by providing essential support to study teams, ensuring timely execution from activation to close-out. Collaborate with diverse stakeholders to drive impactful research...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$93K - $153K *

Accelerate clinical trial success by providing essential support to study teams, ensuring timely execution from activation to close-out while collaborating with various stakeholders to enhance patient...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$93K - $153K *

Join a team that's dedicated to advancing clinical trials, providing essential support to study teams, and ensuring timely execution of studies. Collaborate with experts to make a meaningful impact on...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$142K - $224K *

Elevate medical device assembly engineering by leading hands-on initiatives that drive quality processes, equipment development, and cross-functional collaboration, ensuring robust product functionali...

3 weeks ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$67K - $101K *

Elevate quality assurance by managing protein-based immunoassays, troubleshooting failures, and leading cross-functional teams to ensure compliance and enhance product performance in a dynamic lab env...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $152K *

Join a team that's focused on advancing BIM standards and practices in multi-discipline projects. Utilize your expertise to lead BIM execution, model coordination, and collaboration, ensuring optimal...

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$80K - $95K *

Drive compliance excellence by conducting reviews, audits, and training to ensure adherence to research regulations. Collaborate with faculty and staff to foster a culture of responsible research cond...

2 weeks ago

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

$95K - $115K *

Transform healthcare engagement by building relationships with HCPs through digital interactions and telephone conversations, promoting products, and achieving sales goals while ensuring compliance wi...

RemoteRemote

1 week ago

  •   Less than 5 years exp.  •   Healthcare

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.