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 - $175K *

Drive your career forward as a Clinical Research Associate, ensuring compliance and quality in clinical trials. Collaborate with site staff, monitor progress, and uphold regulatory standards to enhanc...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$90K - $175K *

Lead the charge in clinical trial success by monitoring sites, ensuring compliance, and enhancing data integrity. Collaborate with teams to drive recruitment and maintain high standards in research pr...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$90K - $175K *

Support clinical trial success by monitoring sites, ensuring compliance, and managing data integrity. Collaborate with teams to implement recruitment strategies and deliver training, contributing to h...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$90K - $175K *

Elevate clinical research standards by ensuring compliance and data integrity through effective site management and monitoring. Collaborate with teams to drive successful trial execution and achieve e...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Lead the post-market quality program for SaMD products, enhancing processes and collaboration across teams to ensure compliance and safety throughout the product lifecycle, including investigations an...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$92K - $176K *

Analyze risk management strategies across departments to enhance efficiency and compliance. Lead assessments, educate teams, and integrate quality risk management into the overall system, ensuring eff...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Join a team that's dedicated to advancing space technology by developing and executing rigorous tests for avionics and electrical subsystems. Your expertise will ensure the reliability and performance...

2 weeks ago

  •   5 - 7 years exp.  •   Energy & Utilities

$80K - $95K *

Drive quality excellence by managing the MRB process and collaborating with cross-functional teams to resolve nonconformances, enhance production quality, and support hardware development in a dynamic...

2 weeks ago

  •   5 - 7 years exp.  •   Staffing

$80K - $95K *

Lead the charge in enhancing manufacturing quality by managing MRB processes, collaborating with cross-functional teams, and driving continuous improvement initiatives in an advanced aerospace environ...

2 weeks ago

  •   5 - 7 years exp.  •   Staffing

$134K - $219K *

Unlock potential by leading global site start-up strategies for complex clinical trials. Drive operational excellence, ensure compliance, and collaborate with cross-functional teams to accelerate stud...

United StatesRemote

Reposted 1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$81K - $122K *

Empower your career by driving technical excellence in manufacturing. Collaborate with teams to enhance processes, troubleshoot issues, and implement improvements while ensuring compliance with safety...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$198K - $268K *

Lead the global GMP/GDP audit organization, enhancing predictive compliance intelligence while mitigating risks through advanced analytics and effective audit strategies...

United StatesRemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$123K - $137K *

Transform quality assurance by leading advanced internal audits to enhance compliance across cardiac assist operations. Drive improvements and coach auditors for regulatory excellence while ensuring r...

3 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$100K - $145K *

Tackle compliance oversight through detailed assessments, reporting, and collaboration with law enforcement partners to ensure program adherence and address deficiencies efficiently across a high-volu...

Reposted 2 weeks ago

  •   5 - 7 years exp.  •   Information Technology

$110K - $183K *

Manage the advancement of clinical evidence strategies to support regulatory submissions and product lifecycle management. Collaborate across functions to optimize clinical evaluations and enhance mar...

Portage, MIRemote

Reposted yesterday

  •   5 - 7 years exp.  •   Healthcare

$130K - $133K *

Advance clinical research by leading site monitoring and management efforts. Ensure compliance with regulatory standards while overseeing study protocols and data integrity. Collaborate with teams to...

RemoteRemote

5 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $115K *

Drive engineering excellence on complex projects, ensuring technical compliance, effective communication, and thorough documentation while supporting project deliverables and managing stakeholder rela...

3 weeks ago

  •   5 - 7 years exp.  •   Staffing

$110K - $130K *

Help us enhance electric reliability by leading transmission and resource adequacy studies, collaborating with stakeholders, and applying advanced project management techniques to improve assessment p...

1 week ago

  •   8 - 10 years exp.  •   Energy & Utilities

$72K - $104K *

Join a team that's dedicated to ensuring aerospace product quality and compliance. Collaborate across departments to enhance processes, perform inspections, and drive continuous improvement initiative...

2 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$100K - $120K *

Lead the charge in developing global regulatory strategies to ensure compliant product launches. Collaborate with cross-functional teams to navigate complex regulations, manage submissions, and build...

2 weeks ago

  •   5 - 7 years exp.  •   Food & Beverages

$95K - $115K *

Lead the charge in developing and implementing agency-wide policies for information collection, ensuring compliance with federal regulations while providing expert analysis and guidance to enhance ope...

1 week ago

  •   Less than 5 years exp.  •   Education, Government & Non-Profit

$95K - $115K *

Elevate your career by leading the development and harmonization of a unified Quality Management System across medical device operations, ensuring compliance and operational excellence through strateg...

3 weeks ago

  •   5 - 7 years exp.  •   Business Services

$81K - $112K *

Join a team that's dedicated to enhancing packaging systems for medical devices. Collaborate across functions to ensure compliance, safety, and efficiency while driving continuous improvement in a fas...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$81K - $112K *

Drive innovative packaging solutions for medical devices by leading projects that ensure compliance, functionality, and sustainability. Collaborate cross-functionally to enhance processes and support...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$81K - $112K *

Transform packaging engineering by leading design and development projects for medical devices. Collaborate cross-functionally to ensure compliance, functionality, and sustainability while driving con...

1 week ago

  •   5 - 7 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.