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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$88K - $125K *

Advance quality standards by collaborating with cross-functional teams to conduct audits, support production needs, and implement continuous improvement initiatives, ensuring excellence in operations...

3 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$88K - $125K *

Transform quality assurance by collaborating cross-functionally to uphold standards, drive continuous improvement, and support production needs through audits and compliance. Engage in meaningful init...

3 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$76K - $95K *

Optimize product safety and quality by leading engineering projects, enhancing manufacturing processes, and ensuring compliance with regulations. Collaborate across teams to drive improvements and imp...

3 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$94K - $120K *

Optimize subcontract negotiation and administration processes, ensuring compliance with government regulations. Drive effective procurement strategies across contract types while collaborating with in...

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$100K - $130K *

Champion corporate governance and compliance by managing entity records, supporting transactions, and ensuring regulatory adherence. Collaborate with legal teams to streamline processes and enhance op...

RemoteRemote

2 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$86K - $165K *

Elevate quality assurance processes by analyzing and implementing compliance standards for hardware, software, and documentation. Collaborate with teams to enhance product quality and ensure adherence...

Reposted 3 days ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$100K - $120K *

Take ownership of electrical engineering projects for nuclear power plants, ensuring design integrity and reliability. Collaborate with multidisciplinary teams to troubleshoot and enhance systems, whi...

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$110K - $130K *

Join a dynamic team to design and enhance electrical systems for nuclear power plants. Collaborate on challenging projects, ensuring reliability and compliance while interfacing with clients and vendo...

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Develop and review engineering design changes for nuclear power plant electrical systems. Collaborate with cross-functional teams, prepare technical specifications, and ensure project adherence to sco...

3 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Join a team that's tackling complex challenges in electrical engineering for nuclear power plants. Collaborate on innovative design and analysis projects ensuring reliability and efficiency across mul...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Join a collaborative engineering team dedicated to designing and modifying electrical systems for nuclear power plants, ensuring reliable operations while interfacing with diverse engineering discipli...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$84K - $129K *

Partner with us to enhance nuclear power plant electrical systems through design and analysis. Collaborate with diverse teams, prepare detailed specifications, and ensure project delivery aligns with...

4 weeks ago

  •   5 - 7 years exp.  •   Technical Services

$165K - $185K *

Advance engineering excellence by developing and executing FEA models for robotic medical devices, ensuring optimal performance and reliability through innovative design and collaboration across multi...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$85K - $98K *

Transform quality assurance processes by leading investigations, driving improvements, and ensuring compliance in medical device and pharmaceutical product lines. Collaborate with cross-functional tea...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$150K - $245K *

Lead the charge in clinical trial operations, managing cross-functional teams to ensure timely, budget-conscious, and high-quality study execution while driving innovation and process improvements acr...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$150K - $245K *

Lead the charge in managing cross-functional clinical studies, ensuring operational excellence, budget adherence, and quality outcomes while mentoring teams and driving innovation in trial management...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$150K - $245K *

Transform clinical trials by leading cross-functional teams, managing budgets, and ensuring quality. Drive innovation and process improvements while overseeing study operations and vendor relationship...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$150K - $245K *

Unlock your potential by leading cross-functional teams in clinical trials, ensuring operational excellence, budget management, and quality oversight while driving innovation and process improvements...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$100K - $130K *

Join a team that's leading innovative building automation projects. Oversee technical guidance, design, and implementation while ensuring customer satisfaction and project success through effective te...

1 week ago

  •   Less than 5 years exp.  •   Technical Services

$90K - $135K *

Transform in vivo pharmacology studies by independently executing disease models across therapeutic areas, ensuring compliance with quality standards while contributing to translational strategies and...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$138K - $145K *

Transform your career by overseeing contract manufacturing operations, ensuring quality and efficiency across diverse product formats. Collaborate with cross-functional teams to drive improvements and...

United StatesRemote

3 days ago

  •   8 - 10 years exp.  •   Food & Beverages

$140K - $193K *

Champion product sustainability by designing automated logistics workflows that enhance operational readiness and streamline data processes for effective lifecycle management in defense or aerospace e...

3 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$86K - $165K *

Engage in rigorous review and compliance of Technical Data Packages, supporting change control for defense systems. Collaborate cross-functionally to ensure quality and standard adherence while mentor...

3 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$86K - $165K *

Lead the charge in managing Technical Data Package changes, ensuring compliance and documentation standards are met. Collaborate with engineers to validate design changes and enhance product quality...

3 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$113K - $145K *

Join a dynamic team to enhance manufacturing processes through cross-functional collaboration, data analysis, and continuous improvement initiatives, ensuring quality and efficiency in production oper...

1 week ago

  •   Less than 5 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.