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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$90K - $110K *

Champion quality excellence by overseeing and implementing robust QA/QC systems, ensuring compliance with federal standards and project specifications while collaborating with diverse stakeholders thr...

5 days ago

  •   8 - 10 years exp.  •   Energy & Utilities

$119K - $221K *

Engage with key accounts to drive sales of advanced Mass Spectrometry solutions. Utilize your expertise to implement growth strategies, nurture customer relationships, and coordinate efforts to achiev...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$173K - $272K *

Drive global product compliance and sustainability strategies across diverse technology solutions. Lead cross-functional teams to ensure regulatory adherence throughout the product lifecycle, fosterin...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$135K - $145K *

Transform manufacturing quality processes by leading risk management and continuous improvement initiatives, ensuring compliance and excellence in medical device production while mentoring teams and d...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$80K - $120K *

Lead the charge in resolving production-related technical issues, collaborating across teams to ensure compliant and efficient build processes while driving continuous improvement and supporting produ...

4 days ago

  •   5 - 7 years exp.  •   Information Technology

$100K - $140K *

Drive technical excellence in non-standard ammunition projects, ensuring compliance and performance through effective leadership of Integrated Product Teams and rigorous assessments of engineering doc...

5 days ago

  •   5 - 7 years exp.  •   Information Technology

$85K - $130K *

Advance your career by collaborating within a dynamic team to design and enhance powerful electrical systems for nuclear facilities, focusing on detailed wiring diagrams and multi-disciplinary enginee...

4 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$175K - $210K *

Empower your career by leading a dynamic team in regulatory communications solutions. Drive client success through innovative project management, ensuring quality delivery and effective onboarding whi...

5 days ago

  •   8 - 10 years exp.  •   Finance & Insurance

$175K - $210K *

Elevate your career by leading a dynamic team in delivering innovative regulatory solutions. Drive client success through effective project management, strategic communication, and hands-on implementa...

5 days ago

  •   8 - 10 years exp.  •   Finance & Insurance

$153K - $283K *

Unlock potential by providing strategic regulatory guidance to energy sector clients. Engage with federal and state regulations, market dynamics, and compliance strategies to support utilities and ren...

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$153K - $283K *

Drive strategic regulatory guidance for energy sector clients, navigating complex compliance and market dynamics. Leverage expertise in federal and state regulations to support utilities and renewable...

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$153K - $283K *

Advance your career by providing strategic regulatory guidance to energy sector clients. Leverage your expertise in compliance and market analysis to navigate complex regulatory environments and suppo...

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$153K - $283K *

Transform the energy landscape by providing strategic regulatory guidance to clients in the electric power and renewable sectors. Leverage your expertise to navigate complex regulations and drive comp...

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$153K - $283K *

Unlock potential by providing strategic regulatory guidance to energy sector clients. Collaborate with utilities and developers to navigate complex regulations, ensuring compliance and optimizing mark...

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$153K - $283K *

Join us to provide strategic regulatory guidance in the energy sector, advising clients on compliance, market rules, and policy developments. Leverage your expertise to navigate complex regulatory lan...

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$153K - $283K *

Transform the energy landscape by providing strategic regulatory guidance to clients in the electric power and renewable sectors, navigating complex compliance and market challenges while fostering st...

1 week ago

  •   11 - 15 years exp.  •   Technical Services

$95K - $110K *

Engage as a key quality leader in a dynamic engineering environment, driving manufacturing excellence and quality initiatives across products and processes while collaborating with cross-functional te...

4 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$110K - $130K *

Partner with us to ensure regulatory compliance and patient safety in global pharmaceutical labeling. Oversee safety labeling processes, manage complex projects, and enhance communication across teams...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$131K - $140K *

Shape the future of clinical genomics by developing automated workflows for NGS assays. Collaborate with cross-functional teams to translate innovative chemistry into robust, scalable processes ready...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$67K - $101K *

Lead the charge in ensuring quality compliance through validation, risk assessment, and cross-functional collaboration. Drive continuous improvement initiatives while supporting audits and maintaining...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$67K - $101K *

Champion quality assurance initiatives by overseeing validation processes, conducting risk assessments, and collaborating with cross-functional teams to ensure compliance with regulatory standards and...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$85K - $120K *

Champion clinical excellence by driving the adoption of innovative Perioperative technologies. Collaborate with healthcare professionals to enhance patient outcomes through evidence-based practices an...

Yesterday

  •   5 - 7 years exp.  •   Business Services

$130K - $170K *

Join a team that's driving innovation in medical device electronics. Lead complex designs, collaborate with cross-functional teams, and provide technical expertise throughout the hardware development...

3 weeks ago

  •   8 - 10 years exp.  •   Business Services

$80K - $95K *

Join our team as a Senior Clinical Laboratory Specialist, where you'll provide technical support for clinical and manufacturing operations, ensuring compliance and efficiency while mentoring staff and...

3 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$138K - $230K *

Transform post-market quality assurance processes as a senior technical authority, ensuring compliance and patient safety across product lines. Lead investigations, enhance data analysis, and drive co...

1 week ago

  •   8 - 10 years exp.  •   Healthcare

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.