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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$205K - $256K *

Partner with us to lead strategic contract compliance and administration, driving operational excellence and revenue optimization across diverse functions. Champion AI and automation initiatives to en...

3 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$146K - $194K *

Collaborate with design teams and suppliers to enhance quality processes, ensuring reliable hardware assemblies. Drive supplier engagement and quality readiness throughout product development, leverag...

2 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$146K - $194K *

Drive supplier quality processes to ensure high reliability and performance of components for advanced surveillance systems. Collaborate cross-functionally to enhance product quality and supplier perf...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$120K - $140K *

Champion compliance and innovation in avionics systems, ensuring adherence to airworthiness standards while driving upgrades and new product development in a collaborative environment...

Mirabel, QCIn-Person

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$110K - $130K *

Elevate your career by leading automation design and implementation in manufacturing. Collaborate with cross-functional teams to enhance operational excellence and drive strategic initiatives, ensurin...

Yesterday

  •   8 - 10 years exp.  •   Business Services

$100K - $120K *

Deliver instrumentation and controls engineering services, ensuring compliance with specifications, budgets, and timelines. Guide projects, support teams, and drive technical excellence to meet client...

3 weeks ago

  •   5 - 7 years exp.  •   Staffing

$149K - $239K *

Join us in driving compliance excellence by managing quality systems and regulatory processes. You'll lead initiatives, assess risks, and promote continuous improvement across global teams to ensure o...

2 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$190K - $220K *

Drive your career by leading a global trade compliance program, ensuring adherence to international regulations while enhancing governance and operational efficiency across a complex business landscap...

United StatesRemote

3 weeks ago

  •   11 - 15 years exp.  •   Business Services

$95K - $115K *

Shape the future of biologics manufacturing by leading process development and optimization for downstream purification. Drive technology transfer and scale-up initiatives while collaborating across t...

Reposted 1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$104K - $128K *

Join a dynamic finance team to develop strategic sourcing and category management strategies, ensuring effective procurement and supplier performance while fostering collaboration across departments i...

1 week ago

  •   5 - 7 years exp.  •   Energy & Utilities

$150K - $180K *

Lead the charge in advancing drug discovery by developing predictive tools and systems. Collaborate with top pharma and AI researchers to enhance decision-making processes and optimize workflows for i...

Today

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Lead innovative manufacturing projects in a dynamic environment, driving quality and efficiency. Collaborate cross-functionally to enhance processes and implement improvements, ensuring successful har...

1 week ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$132K - $178K *

Lead a dynamic team to optimize quality oversight through data-driven insights, ensuring compliance and continuous improvement in R&D processes. Drive governance and operational excellence in quality...

United StatesRemote

4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Join a dynamic team as a Sr. Scientist, specializing in method establishment and validation for Drug Substances and Products. Leverage your expertise in cGMP laboratories to drive innovative testing s...

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$282K - $344K *

Elevate global regulatory strategies for product development, ensuring compliance and driving innovation. Collaborate with cross-functional teams to navigate complex regulatory landscapes and lead hig...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$282K - $344K *

Lead the charge in developing global regulatory strategies that drive product development and compliance. Collaborate with cross-functional teams to ensure alignment with clinical and commercial objec...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$282K - $344K *

Advance global regulatory strategies for product development, ensuring compliance and driving innovation. Collaborate with cross-functional teams to align regulatory planning with clinical and commerc...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$90K - $120K *

Lead the charge in talent acquisition and employee relations, shaping a positive workplace culture. Collaborate with HR to attract top talent and enhance employee engagement, making a meaningful impac...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Unlock potential by driving innovative immunology research through hands-on development and execution of bioanalytical assays. Collaborate with cross-functional teams to advance nucleic acid therapeut...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$108K - $130K *

Lead the charge in commissioning and qualification of equipment and systems, ensuring compliance with global standards and regulatory requirements while guiding junior engineers and collaborating with...

1 week ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$131K - $237K *

Lead the charge in designing and analyzing mechanical systems for Unmanned Underwater Vehicles (UUVs). Collaborate across disciplines, mentor junior engineers, and ensure innovative solutions meet cus...

Yesterday

  •   8 - 10 years exp.  •   Technical Services

$85K - $130K *

Elevate your career by leading mechanical design projects, collaborating with multi-disciplined teams to create innovative 3D models and layouts. Drive efficiency and quality in mechanical deliverable...

3 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$134K - $205K *

Play a key role in ensuring quality standards for heavy industrial construction projects. Collaborate with contractors to oversee compliance, conduct audits, and maintain documentation, ensuring peak...

United StatesRemote

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$117K - $176K *

Pioneer supply chain excellence by leading material strategy and procurement efforts. Collaborate with cross-functional teams to ensure timely delivery and optimal resource allocation, driving mission...

2 days ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$112K - $168K *

Join a dynamic team as a Principal Supply Chain Program Planner, overseeing material budgets and supplier management. Drive supply chain activities from development to production, ensuring alignment w...

Reposted 1 week ago

  •   5 - 7 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.