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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$86K - $165K *

Empower our supply chain excellence by managing supplier quality, driving systemic improvements, and ensuring compliance. Collaborate across functions to boost performance and sustainability while lev...

Texas, USRemote

Reposted 5 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$80K - $110K *

Lead the charge in enhancing equipment reliability and performance within a GMP-regulated environment. Drive asset management strategies, optimize maintenance practices, and collaborate across teams t...

Arnprior, ONIn-Person

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$114K - $131K *

Engage with Tier 1 clients as a Senior Sales Specialist, leading a team to drive revenue growth through strategic sales of data solutions. Collaborate across units to enhance client experiences and co...

6 days ago

  •   8 - 10 years exp.  •   Finance & Insurance

$100K - $135K *

Shape the future of pharmaceutical validation by leading technical work streams, mentoring junior staff, and ensuring compliance with cGMP standards. Drive project success through expert problem-solvi...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$113K - $150K *

Drive supplier quality initiatives by managing audits, compliance evaluations, and corrective actions. Collaborate with suppliers to enhance quality standards and ensure alignment with regulatory requ...

Reposted 3 days ago

  •   5 - 7 years exp.  •   Healthcare

$120K - $145K *

Elevate your career as a technical authority, guiding strategic advancements in manufacturing science and technology. Influence decisions, mentor teams, and drive innovative solutions throughout produ...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Empower growth by leveraging technical sales expertise to enhance customer relationships and promote innovative life sciences products, driving advancements in research and manufacturing capabilities...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Drive excellence in clinical research by overseeing site management, ensuring compliance, and fostering collaboration among stakeholders to achieve study milestones efficiently and effectively...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Champion the delivery of clinical studies by monitoring site performance, ensuring compliance, and collaborating with local teams to achieve study milestones efficiently and effectively...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Join us to drive clinical study success by overseeing site selection, monitoring, and compliance. Collaborate with cross-functional teams to ensure timely delivery and quality in clinical trials, whil...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Lead the charge in clinical research by ensuring study compliance and performance at assigned sites. Collaborate with cross-functional teams to drive timely delivery of study milestones while maintain...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Lead the delivery of clinical studies at assigned sites, ensuring compliance and timely execution. Collaborate with cross-functional teams to drive performance, resolve issues, and support site staff...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$88K - $105K *

Grow your career with a dynamic role overseeing clinical studies, ensuring compliance and performance at assigned sites. Collaborate with cross-functional teams to drive successful study delivery and...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Innovate regulatory compliance and product safety strategies while managing labeling and documentation for food products. Collaborate across departments to minimize risks and ensure adherence to evolv...

1 week ago

  •   5 - 7 years exp.  •   Food & Beverages

$109K - $179K *

Join a team that's shaping regulatory strategies for advertising and promotion. Leverage your expertise to ensure compliance while collaborating with cross-functional teams to drive impactful product...

United StatesRemote

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$156K - $247K *

Grow your expertise by enhancing drug delivery device technologies through hands-on leadership and technical innovation. Collaborate cross-functionally to advance device functionality and identify opp...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$134K - $219K *

Collaborate across functions to establish and maintain enterprise data stewardship standards, ensuring clarity of definitions, roles, and accountability while driving consensus on shared planning conc...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$85K - $133K *

Lead the charge in ensuring compliance and patient safety within the medical device sector. Collaborate with cross-functional teams to investigate adverse events and regulatory reporting, driving qual...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$85K - $133K *

Join a dynamic team to ensure compliance and patient safety in the medical device sector. Collaborate across functions to investigate adverse events and enhance regulatory reporting, making a signific...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$134K - $219K *

Discover a pivotal role in establishing enterprise data stewardship standards, leading cross-domain collaboration, and ensuring consistency in planning data definitions and accountability across funct...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Transform global entity management by coordinating across Finance, HR, and Legal. Ensure compliance, maintain corporate records, and build scalable processes as we expand internationally. Drive operat...

CanadaRemote

3 weeks ago

  •   Less than 5 years exp.  •   Enterprise Technology

$178K - $307K *

Elevate quality management by leading CAPA processes and issue resolution. Drive continuous improvement initiatives across a global team, ensuring compliance and fostering a culture of accountability...

1 week ago

  •   11 - 15 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Lead regulatory compliance efforts in the A220 Quality Assurance team, ensuring operational processes meet quality standards and certifications. Collaborate with cross-functional teams to address non...

Montreal, QCIn-Person

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$134K - $219K *

Innovate enterprise planning processes by defining standards, managing templates, and leading integrations across platforms. Collaborate with cross-functional teams to ensure effective implementation...

5 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$134K - $219K *

Transform enterprise planning by leading process standards and technical integration. Collaborate across functions to ensure effective use of planning tools, manage templates, and drive continuous imp...

5 days 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.