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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$64K - $128K *

Support compliance programs and initiatives, manage complex regulatory reviews, and collaborate with teams to ensure adherence to investment guidelines and securities laws, enhancing the organization...

4 weeks ago

  •   Less than 5 years exp.  •   Finance & Insurance

$58K - $102K *

Lead logistics trade compliance initiatives, managing operational activities and ensuring adherence to import/export regulations. Collaborate with cross-functional teams to enhance compliance processe...

3 weeks ago

  •   Less than 5 years exp.  •   Food & Beverages

$58K - $102K *

Shape the future of trade compliance by coordinating import/export operations, ensuring adherence to regulations, and partnering with cross-functional teams to optimize logistics processes and maintai...

3 weeks ago

  •   Less than 5 years exp.  •   Food & Beverages

$100K - $126K *

Lead the charge in developing innovative cell-based assays to drive discovery programs. Collaborate cross-functionally to enhance platform growth and contribute to in vivo pharmacology activities, ens...

Reposted 1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$145K - $276K *

Lead a dynamic team of Manufacturing Supplier Quality Engineers to enhance product quality, drive continuous improvement, and ensure compliance with industry standards while collaborating with cross-f...

1 week ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$85K - $105K *

Join a team that's dedicated to advancing clinical research by leading negotiations and managing Clinical Trial Agreements. This role ensures timely study startup, effective issue resolution, and ment...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $181K *

Unlock innovative solutions by developing advanced signal processing and control systems. Collaborate with a dynamic team to tackle complex challenges in physical systems, ensuring impactful results f...

Reposted 5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$83K - $150K *

Join our team to lead quality initiatives, ensuring product excellence through robust quality plans and statistical analysis. Collaborate across departments to resolve discrepancies and drive continuo...

Yesterday

  •   5 - 7 years exp.  •   Consumer Technology

$80K - $95K *

Engage with a dynamic team to enhance and sustain a robust Quality program, driving process improvements and ensuring compliance, while developing analytical dashboards and monitoring key metrics to s...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Energy & Utilities

$80K - $95K *

Join a team that's transforming local government operations through innovative SaaS implementations. Lead complex projects, collaborate with clients, and drive measurable outcomes while enhancing your...

CanadaRemote

4 days ago

  •   Less than 5 years exp.  •   Enterprise Technology

$80K - $100K *

Elevate quality standards by conducting analytical testing in a GMP environment. Collaborate with a dynamic team to ensure compliance and excellence in documentation and testing for clinical and comme...

5 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Partner with us to drive innovation in drug product development by supporting analytical method validation and improvement. Collaborate on formulation and testing while ensuring compliance with indust...

1 month ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join a dynamic team to conduct quality inspections and ensure compliance in a fast-paced medical device environment. Collaborate on innovative projects while maintaining high standards for product qua...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $134K *

Shape the future of operational resilience by leading advanced test engineering efforts, ensuring system verification and validation, and enhancing software and hardware delivery for mission-critical...

Yesterday

  •   11 - 15 years exp.  •   Technical Services

$142K - $256K *

Bring your expertise to a vital role enhancing investigation excellence and operational performance. Drive systemic improvements and maintain compliance to ensure inspection readiness across multiface...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$78K - $98K *

Lead the charge in overseeing supplier manufacturing of large structural components for complex nuclear projects. Ensure compliance with quality standards, resolve manufacturing issues, and enhance pr...

Kitchener, ONIn-Person

3 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$80K - $95K *

Join a team that's dedicated to enhancing quality and compliance in Life Sciences. In this pivotal role, you'll drive quality management, support regulatory standards, and collaborate across functions...

3 weeks ago

  •   5 - 7 years exp.  •   Business Services

$103K - $154K *

Lead the charge in ensuring robust, compliant, and cost-effective manufacturing processes for clinical and commercial cell therapy products, focusing on technical support, continuous improvement, and...

Reposted 3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $205K *

Champion product regulatory compliance for pool and spa equipment. Lead a team to ensure safety, energy efficiency, and environmental standards are met throughout the product lifecycle, collaborating...

1 week ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$110K - $205K *

Lead and shape the regulatory compliance strategy for pool and spa products, ensuring adherence to safety and environmental standards while managing a team and collaborating across functions to suppor...

1 week ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$110K - $130K *

Elevate project outcomes by leading cross-functional teams to deliver clinical research projects on time and within budget, ensuring compliance with regulatory standards and client expectations while...

United StatesRemote

2 days ago

  •   Less than 5 years exp.  •   Healthcare

$95K - $115K *

Join a team that's redefining materials management in a fast-paced environment. Lead inventory control, oversee warehouse operations, and ensure timely delivery of materials for innovative production...

1 week ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$120K - $155K *

Drive innovative mechanical process designs for complex research facilities. Lead multidisciplinary teams, ensuring project success from concept to execution while maintaining high standards in a dyna...

3 days ago

  •   8 - 10 years exp.  •   Technical Services

$120K - $155K *

Innovate and lead multidisciplinary teams to design complex mechanical systems for advanced research facilities, ensuring project success through effective management of scope, budget, and schedule wh...

4 days ago

  •   8 - 10 years exp.  •   Technical Services

$120K - $155K *

Lead the charge in designing and managing complex mechanical process systems for cutting-edge research facilities, ensuring high-quality solutions and client satisfaction while collaborating with mult...

4 days ago

  •   8 - 10 years exp.  •   Technical Services

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.