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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$100K - $120K *

Drive your career with a Senior Process Engineer role, ensuring compliant and efficient sterile manufacturing processes from concept to launch. Lead continuous improvement initiatives and serve as a S...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$90K - $105K *

Unlock your potential by supporting legislative and regulatory initiatives that drive project development. Collaborate with cross-functional teams to translate business needs into effective policy str...

1 week ago

  •   Less than 5 years exp.  •   Enterprise Technology

$134K - $219K *

Drive operational excellence in Clinical Supply Logistics, leading a team to enhance processes, manage vendor relationships, and implement continuous improvements while leveraging data insights for st...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Optimize product quality by leading engineering projects, ensuring compliance with ISO and QSR regulations, and working collaboratively across departments to enhance performance and maintain high stan...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$125K - $150K *

Elevate your career by leading strategic pharma partnerships, driving program delivery for innovative digital health solutions. Manage diverse workstreams and foster executive relationships to ensure...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Food & Beverages

$76K - $99K *

Lead the charge in implementing a robust risk-based surveillance program, ensuring contractor compliance and quality assurance for diverse products. Collaborate with multi-functional teams to enhance...

4 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$83K - $108K *

Drive quality assurance initiatives by designing and implementing risk-based surveillance programs, ensuring contractor compliance, and enhancing processes to support diverse products and services for...

4 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$88K - $114K *

Lead the charge in implementing a risk-based quality assurance program, ensuring contractor compliance and enhancing processes through data analysis. Collaborate with multi-functional teams to support...

4 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$82K - $106K *

Drive quality assurance initiatives by designing and implementing risk-based surveillance programs, ensuring contractor compliance, and enhancing processes to support diverse products and services for...

4 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$82K - $111K *

Join us to implement a risk-based quality assurance program, ensuring contractor compliance and enhancing processes. Collaborate with multi-functional teams to support U.S. Government acquisitions in...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$84K - $109K *

Join a team that's shaping the future of quality assurance in high-stakes environments. You'll design and implement risk-based programs, ensuring compliance and enhancing processes while supporting U...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$74K - $97K *

Lead the development and implementation of a risk-based quality assurance program, ensuring contractor compliance and enhancing processes through data analysis. Collaborate with multi-functional teams...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$88K - $114K *

Engage in quality assurance by designing and implementing risk-based programs, ensuring contractor compliance, and analyzing data for process improvements in support of U.S. Government acquisitions in...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$78K - $101K *

Contribute to quality assurance by designing and implementing risk-based programs, ensuring contractor compliance, and analyzing data for process improvements in support of U.S. Government acquisition...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$82K - $106K *

Take ownership of quality assurance processes by designing and implementing risk-based surveillance programs. Collaborate with multi-functional teams to ensure contractor compliance and enhance operat...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$85K - $111K *

Shape the future of quality assurance by implementing risk-based programs and ensuring contractor compliance in diverse environments. Collaborate with multi-functional teams to enhance processes and s...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$74K - $97K *

Join a team that's dedicated to enhancing quality assurance in diverse environments. This role involves deploying to austere locations, implementing risk-based programs, and ensuring contractor compli...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$78K - $101K *

Unlock your potential by leading quality assurance initiatives in high-stakes environments. Collaborate with multi-functional teams to enhance contractor compliance and drive process improvements whil...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$76K - $99K *

Engage in quality assurance by designing and implementing risk-based surveillance programs. Collaborate with multi-functional teams to ensure contractor compliance and enhance processes, supporting U...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$82K - $106K *

Partner with us to implement a risk-based quality assurance program, ensuring contractor compliance and enhancing processes in diverse environments. Engage in audits, data analysis, and technical supp...

5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$95K - $110K *

Manage strategic supplier relationships and optimize procurement processes to ensure seamless material flow for manufacturing. Collaborate cross-functionally to drive cost savings and efficiency in a...

3 weeks ago

  •   5 - 7 years exp.  •   Staffing

$95K *

Unlock potential by joining a dynamic team focused on enhancing healthcare quality through data analysis and compliance. Collaborate with operational leaders to drive improvements and ensure exception...

2 days ago

  •   Less than 5 years exp.  •   Healthcare

$150K - $185K *

Contribute to the design and integration of complex electromechanical systems in medical devices. Leverage expertise in FDA submissions and cross-functional collaboration to ensure compliance, safety...

3 weeks ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$110K - $130K *

Join us to lead product management of medical therapeutics, diagnostics, and clinical protocols. Engage in regulatory coordination with FDA and IRB. Drive IND accountability and support innovative sol...

3 weeks ago

  •   Less than 5 years exp.  •   Business Services

$94K - $176K *

Join a team that's dedicated to ensuring supplier quality excellence. This role involves managing supplier evaluations, compliance, and performance while traveling extensively to support quality assur...

6 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

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.