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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$134K - $219K *

Lead clinical laboratory operations for precision medicine projects, ensuring timely deliverables and risk management across therapeutic areas. Collaborate with cross-functional teams to support clini...

RemoteRemote

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Lead quality assurance initiatives, collaborate across teams, and ensure compliance with standards. Drive continuous improvement programs and support operations with data-driven insights in a dynamic...

Reposted 5 days ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$130K - $160K *

Join a team that's driving innovation in energy storage by leading product design, mentoring engineers, and optimizing manufacturing processes for battery systems and components, ensuring excellence f...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$119K - $150K *

Lead the charge in implementing and maintaining Global Quality Systems, focusing on LIMS. Collaborate with cross-functional teams to ensure compliance and drive continuous improvement in quality manag...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$94K - $128K *

Drive project execution in an FDA-regulated environment, coordinating timelines, documentation, and interdepartmental communication to ensure successful outcomes and regulatory compliance while managi...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$150K - $200K *

Lead innovative research in immunology, focusing on autoimmune diseases. Design and execute experiments, analyze data, and collaborate with cross-functional teams to guide drug development from early...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Drive supplier quality assurance for pharmaceutical operations, ensuring compliance with CGMP and FDA regulations. Oversee supplier lifecycle management, lead audit teams, and collaborate with cross-f...

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$63K - $100K *

Engage in analytical testing and support CMC Development programs by operating and troubleshooting advanced instrumentation. Collaborate in a fast-paced lab environment to deliver high-quality data an...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Shape the future of global sales strategy by leading commercial efforts, driving revenue growth, and enhancing customer engagement across diverse market segments in a dynamic, collaborative environmen...

RemoteRemote

4 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$85K - $95K *

Help us ensure code compliance in building permits while collaborating across teams to enhance operational efficiency and innovation. Leverage your expertise to support residential and commercial proj...

4 weeks ago

  •   5 - 7 years exp.  •   Real Estate & Construction

$100K - $120K *

Accelerate progress at the forefront of chromatography sales, driving revenue growth through strategic account management and collaboration with internal teams to deliver customer solutions across a d...

RemoteRemote

3 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$117K - $184K *

Transform your career by leading innovative analytical solutions in a dynamic team. Drive efficiency and quality in pharmaceutical development while collaborating with cross-functional experts to enha...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$180K - $335K *

Serve as a key legal advisor on government contracts, guiding compliance and risk management while mentoring junior attorneys. Oversee contract negotiations and ensure adherence to regulations, contri...

2 weeks ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$180K - $335K *

Champion a pivotal role in government contracts law, providing expert legal guidance on U.S. government programs while mentoring junior attorneys and ensuring compliance across all phases of the contr...

2 weeks ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$66K - $116K *

Elevate your career by joining a team that reviews and edits informed consent forms, ensuring compliance with regulatory standards while mentoring new editors and enhancing organizational knowledge in...

United StatesRemote

3 days ago

  •   Less than 5 years exp.  •   Healthcare

$81K - $122K *

Shape the future of cell therapy by driving process development and optimization. Collaborate cross-functionally to enhance scalability and compliance, ensuring robust manufacturing processes for clin...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$141K - $261K *

Unlock potential by leading Quality Assurance strategies and audits for post-approval products. Collaborate with stakeholders to ensure compliance and drive process improvements while mentoring team m...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$130K - $160K *

Inspire a high-performing team to execute robust sterility assurance strategies, ensuring compliance and continuous improvement in a regulated environment. Collaborate with stakeholders to enhance qua...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Elevate your career by implementing cost control systems for large-scale EPC projects. Collaborate with diverse teams to analyze performance, prepare forecasts, and support change management, ensuring...

2 days ago

  •   5 - 7 years exp.  •   Energy & Utilities

$190K - $220K *

Join a team that's shaping the future of global clinical trials by providing expert legal guidance on commercial transactions, regulatory compliance, and continuous improvement of legal processes whil...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$190K - $220K *

Lead the legal function by managing commercial agreements and advising on compliance. Collaborate with business teams to ensure rapid deal execution while mitigating risks. Drive process improvements...

Johnson City, TNRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$100K - $152K *

Unlock your potential by working in a collaborative team to design, analyze, and improve complex control systems in nuclear power plants, focusing on innovative solutions and critical project executio...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$80K - $95K *

Empower compliance excellence across Latin America by partnering with stakeholders to mitigate risks and drive ethical business practices. Support the implementation of compliance initiatives while na...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$250K - $280K *

Transform our Quality Assurance landscape by leading a high-performing team, ensuring compliance across GxP functions, and driving strategic quality initiatives that align with corporate objectives an...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$134K - $219K *

Empower clinical laboratory operations by managing projects across therapeutic areas, ensuring timely study starts and data delivery while collaborating with cross-functional teams to mitigate risks a...

2 weeks ago

  •   8 - 10 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.