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.

Remote
caret down
Compensation
caret down
Position Level
caret down
Time Posted
caret down
Industries
caret down
Locations
caret down
More
1
caret down

$83K - $95K *

Drive validation of Chemistry and Immunoassay instruments, ensuring compliance with specifications and regulatory standards. Collaborate with customers and internal teams to provide training and suppo...

1 week ago

  •   Less than 5 years exp.  •   Business Services

$83K - $95K *

Lead the charge in validating Chemistry and Immunoassay instruments, ensuring compliance with specifications and regulatory standards while providing training and support to customers in the Mid-Atlan...

1 week ago

  •   Less than 5 years exp.  •   Business Services

$80K - $125K *

Manage the full subcontract lifecycle, ensuring compliance and effective collaboration with stakeholders to mitigate risks and facilitate project success in a dynamic environment...

Reposted today

  •   8 - 10 years exp.  •   Technical Services

$96K - $151K *

Unlock your potential by driving strategic supplier management and procurement initiatives. Collaborate across divisions to enhance supply chain resilience, optimize costs, and support innovative prod...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$96K - $151K *

Optimize supplier management strategies to enhance supply chain resilience, drive cost improvements, and support product development initiatives. Collaborate across teams to ensure effective sourcing...

Yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$121K - $193K *

Lead the charge in driving EU MDR compliance initiatives by managing cross-functional programs, ensuring timely delivery of regulatory milestones while optimizing resources and stakeholder engagement...

3 days ago

  •   5 - 7 years exp.  •   Healthcare

$135K - $216K *

Lead and optimize EU MDR compliance initiatives, managing cross-functional programs to ensure timely delivery of regulatory milestones while aligning with business objectives and proactively addressin...

3 days ago

  •   5 - 7 years exp.  •   Healthcare

$61K - $122K *

Optimize regulatory operations by ensuring compliance with evolving standards, managing audit readiness, and collaborating with cross-functional teams to maintain an effective quality system in a dyna...

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Champion quality excellence by leading the development and implementation of robust quality systems. Drive continuous improvement and ensure compliance with safety and regulatory standards while foste...

1 week ago

  •   8 - 10 years exp.  •   Energy & Utilities

$76K - $110K *

Lead operational excellence in Medical and Clinical Affairs, managing grants, coordinating cross-functional teams, and ensuring efficient program execution to enhance healthcare outcomes and support s...

Woburn, MARemote

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$76K - $110K *

Champion operational excellence in Medical and Clinical Affairs, overseeing grant management, project coordination, and cross-functional collaboration to drive strategic initiatives and ensure high-qu...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$145K - $234K *

Grow your career with us as you support risk management practices, assess technology and cybersecurity risks, and enhance governance reporting in a dynamic, regulated environment. Collaborate cross-fu...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$89K - $141K *

Champion data-driven insights by leading quality analytics initiatives, ensuring compliance and operational excellence in R&D. Collaborate with stakeholders to design impactful dashboards and enhance...

Reposted 4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$272K - $409K *

Pioneer regulatory excellence in medical devices. Lead a global team to drive product approvals, ensure compliance, and shape strategic direction for the Radiology portfolio, optimizing value and fost...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $120K *

Join a dynamic team as a Senior QC Scientist, where you'll coordinate Quality Control activities, ensuring compliance and timely testing across projects. Collaborate with cross-functional teams to uph...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$96K - $151K *

Empower your career by joining a dynamic team focused on validating cutting-edge analytical instruments in a GMP environment. Collaborate globally to ensure compliance and drive operational excellence...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $125K *

Lead the charge in overseeing clinical studies to enhance organ preservation through innovative research and management strategies, ensuring compliance and data integrity across multiple protocols and...

Reposted 4 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$95K - $115K *

Lead the charge in developing innovative manufacturing systems for medical devices, ensuring compliance with industry regulations while optimizing processes from pilot to full-scale production...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Join a team that's dedicated to advancing eye health by leading the development of innovative inspection systems for automated medical-device manufacturing, ensuring quality and reliability in product...

2 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$90K - $105K *

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

United StatesRemote

Reposted 1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$109K - $174K *

Lead the charge in developing next-gen surgical navigation systems for orthopaedics. Collaborate across teams to ensure clear, traceable requirements and deliver safe, reliable solutions that enhance...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$109K - $174K *

Shape the future of surgical navigation systems in orthopaedics. As a Senior Systems Engineer, you'll drive system requirements, risk analysis, and interface definitions, collaborating with cross-func...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$126K - $138K *

Lead internal quality audits to ensure compliance with ISO 13485 and FDA regulations. Play a key role in improving QMS processes, managing audit findings, and supporting certification efforts within t...

Reposted 4 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$80K - $95K *

Champion end-to-end trade compliance and global operations for regulated supply chains. Drive import/export processes, ensuring adherence to standards while collaborating with cross-functional teams t...

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$120K - $145K *

Lead the charge in ensuring quality assurance for transport and packaging validation, collaborating with cross-functional teams to uphold compliance and readiness for commercial drug products while ma...

1 week 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.