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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$84K - $129K *

Transform nuclear engineering projects by leading electrical design and modifications. Collaborate with multidisciplinary teams to ensure project success, manage technical interfaces, and deliver high...

2 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Transform the future of clean energy by leading electrical engineering projects for nuclear plant modifications. Collaborate with multidisciplinary teams to ensure technical excellence and project suc...

2 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$100K - $152K *

Drive innovative electrical designs within nuclear power projects, collaborating with diverse teams to enhance system reliability and performance. Address complex engineering challenges while ensuring...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$100K - $152K *

Elevate your career by solving complex electrical engineering challenges in nuclear power. Engage with multi-disciplinary teams to ensure project delivery, from design through installation, while supp...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$114K - $143K *

Champion the successful execution of cross-functional programs, driving product launches and overseeing clinical studies. Focus on risk mitigation and value delivery to ensure compliance and excellenc...

4 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$110K - $130K *

Join a team that's dedicated to regulatory compliance and product stewardship, leading efforts across markets in North America. Oversee daily operations, drive continuous improvement, and cultivate a...

RemoteRemote

Reposted 2 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$140K - $185K *

Drive innovation in advanced heat exchanger systems, collaborating with cross-functional teams to design, analyze, and validate high-performance solutions for next-generation energy applications, ensu...

2 weeks ago

  •   5 - 7 years exp.  •   Energy & Utilities

$140K - $185K *

Transform the thermal management of the Power Conversion System, owning the heat budget and critical thermal interfaces. Collaborate across disciplines to optimize hardware performance while ensuring...

Reposted 4 weeks ago

  •   5 - 7 years exp.  •   Energy & Utilities

$100K - $152K *

Lead the charge in nuclear power systems design by preparing modification packages and engineering evaluations that enhance operational efficiency and accuracy in nuclear plants. Engaging with clients...

1 month ago

  •   5 - 7 years exp.  •   Technical Services

$110K - $130K *

Champion innovative mechanical designs for space nuclear systems, overseeing the entire lifecycle from concept to integration. Collaborate across disciplines to ensure mission success and drive system...

Yesterday

  •   5 - 7 years exp.  •   Energy & Utilities

$100K - $152K *

Join a team that's dedicated to advancing nuclear power systems design, collaborating on modification packages, engineering evaluations, and leading project initiatives that ensure operational excelle...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$100K - $152K *

Transform nuclear power plant systems design by leading modification packages, technical evaluations, and engineering analyses, while collaborating with clients and spearheading project teams to enhan...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$100K - $152K *

Analyze nuclear power systems design and contribute to modifications, engineering analyses, and procurement processes while leading teams. Collaborate effectively with clients and support high-quality...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$100K - $152K *

Manage the design and analysis of nuclear power plant systems, ensuring compliance with industry standards. Collaborate with project teams to develop modifications and specifications, guiding projects...

1 month ago

  •   5 - 7 years exp.  •   Technical Services

$80K - $95K *

Unlock your potential by supporting pharmacovigilance processes, managing ICSR activities, and ensuring compliance with regulations. Collaborate with a global team to enhance safety management and con...

Raleigh, NCRemote

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Drive excellence in pharmacovigilance by managing ICSR processes, ensuring compliance, and supporting project teams. Collaborate with global colleagues to enhance safety reporting and contribute to cl...

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Shape regulatory compliance strategies for chemical products in the Americas, ensuring adherence to regional legislation while fostering sustainable product development and stewardship initiatives acr...

4 weeks ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$83K - $101K *

Transform quality assurance by overseeing investigations, ensuring compliance, and driving continuous improvement in a fast-paced team environment. Engage with cross-functional teams to uphold high st...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Transform clinical data management practices by overseeing data activities from study initiation to close-out, ensuring quality timelines and compliance. Collaborate with stakeholders to drive efficie...

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$84K - $129K *

Shape the future of clean energy by contributing to the structural analysis and design of nuclear power facilities. Collaborate with a multidisciplinary team on innovative projects, applying your expe...

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Shape innovative engineering solutions in structural design and analysis. Lead projects, collaborate with multidisciplinary teams, and apply advanced techniques for safety-related structures in nuclea...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Transform your career by leading structural engineering projects, collaborating with cross-disciplinary teams, applying advanced analysis techniques, and guiding others as you work towards innovative...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$125K - $148K *

Lead the charge in Quality Management System compliance and CAPA processes, driving complex investigations and audits while fostering cross-functional collaboration and coaching. Ensure effective risk...

Reposted 4 days ago

  •   8 - 10 years exp.  •   Healthcare

$230K - $260K *

Lead and execute global Regulatory CMC strategies for advanced therapies, ensuring compliance and supporting late-stage development and commercialization. Collaborate with cross-functional teams to dr...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$114K - $187K *

Transform your career by leading IRT systems for clinical trials, collaborating across teams to ensure successful project execution and delivery. Join a dynamic environment where your expertise will d...

2 weeks ago

  •   Less than 5 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.