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

$122K - $176K *

Strategize and lead regulatory strategies for advertising and promotions, ensuring compliance and effectiveness. Work cross-functionally to maximize product impact and navigate complex medical environ...

Reposted 2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Champion quality assurance initiatives by managing complex deviations and CAPA systems. Collaborate with stakeholders to enhance compliance and operational excellence while driving process improvement...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$79K - $93K *

Elevate quality standards in construction by implementing and auditing compliance procedures. Collaborate with project teams to ensure adherence to industry codes and enhance training initiatives, dri...

2 weeks ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$110K - $130K *

Unlock potential by serving as a subject matter expert in procurement compliance, guiding complex regulatory matters, and enhancing audit readiness. Collaborate with stakeholders to ensure consistent...

3 days ago

  •   8 - 10 years exp.  •   Staffing

$110K - $125K *

Join a team that's dedicated to enhancing contamination control and sterility assurance across multiple manufacturing sites. Lead strategic initiatives to ensure compliance, operational excellence, an...

2 weeks ago

  •   8 - 10 years exp.  •   Business Services

$110K - $125K *

Champion contamination control and sterility assurance across multiple sites, driving strategic initiatives and compliance to enhance product quality and patient safety while ensuring operational exce...

2 weeks ago

  •   8 - 10 years exp.  •   Business Services

$110K - $125K *

Join us in leading contamination control and sterility assurance programs across multiple manufacturing sites, ensuring compliance and operational excellence while enhancing product quality and patien...

2 weeks ago

  •   8 - 10 years exp.  •   Business Services

$110K - $125K *

Empower our contamination control and sterility assurance initiatives across multiple manufacturing sites, ensuring compliance and operational excellence while enhancing product quality and patient sa...

2 weeks ago

  •   8 - 10 years exp.  •   Business Services

$110K - $130K *

Drive excellence in quality management systems by ensuring compliance with ISO 13485:2016 and regulatory standards. Collaborate cross-functionally to enhance quality culture, support audits, and lead...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$130K - $155K *

Lead quality assurance and regulatory compliance efforts in a dynamic life sciences environment. Drive modernization through automation and AI, ensuring adherence to GxP standards while enhancing insp...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Champion compliance excellence by leading privacy initiatives, conducting investigations, and ensuring adherence to regulations. Collaborate with teams to enhance processes and mitigate risks while se...

Yesterday

  •   5 - 7 years exp.  •   Healthcare

$64K - $133K *

Engage in complex large-molecule bioanalytical method development, leading scientific studies and collaborating with clients to deliver innovative solutions that support drug development programs...

Reposted 2 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $193K *

Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...

United StatesRemote

Reposted 1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$140K - $160K *

Elevate quality assurance standards by leading a skilled team to develop, implement, and maintain robust quality management systems for critical IT solutions, ensuring compliance and operational excel...

2 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$222K - $303K *

Join us to lead global regulatory strategy for innovative development programs, ensuring alignment with business objectives and efficient lifecycle management across major markets while influencing ke...

New Jersey, USRemote

Reposted today

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$167K - $207K *

Lead the charge in shaping regulatory operations by enhancing submission processes, governance, and systems. Drive high-quality global submissions while fostering collaboration and visibility across t...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$124K - $207K *

Drive data excellence by overseeing global regulatory data management activities, ensuring integrity and quality across multiple regions and products. Collaborate with cross-functional teams to innova...

4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$124K - $207K *

Unlock potential by overseeing global data management activities, ensuring data integrity and quality across regulatory systems. Drive innovation and efficiency through strategic initiatives, while co...

4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$78K - $156K *

Join a dynamic team as you manage complex commercial contracts, balancing legal and business needs. Collaborate with cross-functional stakeholders to drive negotiations and enhance contracting process...

Durham, NCRemote

Reposted 2 days ago

  •   5 - 7 years exp.  •   Healthcare

$135K - $145K *

Elevate your career by managing laboratory and biospecimen operations for clinical studies. Oversee vendor performance, ensure compliance, and mentor team members while driving project success across...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$88K - $121K *

Optimize the release management of finished goods, ensuring compliance with food safety and regulatory standards while leading a team to address non-conformance and enhance quality assurance processes...

1 week ago

  •   Less than 5 years exp.  •   Food & Beverages

$117K - $184K *

Join a dynamic team to lead vaccine technology transfers, ensuring compliance and efficiency. Drive cross-functional projects, mentor new talent, and enhance process robustness in a fast-paced biophar...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Manage a regulatory team to ensure compliance with FDA and Health Canada standards. Drive regulatory strategy for product innovation and oversee compliance assessments, while collaborating with cross...

3 weeks ago

  •   11 - 15 years exp.  •   Food & Beverages

$110K - $130K *

Empower product compliance and approvals by overseeing regulatory submissions, collaborating with teams, and delivering insights on regulations for medical devices through their lifecycle. Your expert...

1 month ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Lead impactful quality systems and compliance initiatives, overseeing deviation, CAPA, and complaints management. Collaborate across functions to enhance quality performance and drive continuous impro...

Reposted today

  •   5 - 7 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.