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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$72K - $94K *

Support compliance initiatives by managing quality systems for global sustainability standards such as EU MDR and REACH. Collaborate with internal teams and ensure adherence to regulations while enhan...

Reposted 2 days ago

  •   Less than 5 years exp.  •   Healthcare

$117K - $184K *

Elevate project execution by leading capital projects from inception to completion. Utilize technical expertise and stakeholder collaboration to ensure safe, compliant, and effective outcomes across d...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$188K - $230K *

Lead the charge in ensuring quality compliance by executing risk-based audits, assessing adherence to GxP regulations, and driving continuous improvement while partnering with cross-functional teams t...

Reposted 4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$188K - $230K *

Unlock potential by leading and executing a comprehensive risk-based Quality audit program, ensuring adherence to GxP regulations and Quality standards. Drive continuous improvement and regulatory rea...

Reposted 4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$84K - $129K *

Unlock potential by engaging in innovative radiological engineering projects, collaborating with multi-discipline teams to enhance nuclear power plants through advanced radiation monitoring and techni...

3 weeks ago

  •   Less than 5 years exp.  •   Technical Services

$78K - $117K *

Drive quality assurance and control for HVAC construction projects, ensuring compliance with standards and safety protocols while collaborating with teams to enhance design and efficiency throughout a...

3 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$95K - $115K *

Champion the development and lifecycle management of innovative drug-device combination products while leading cross-functional teams to ensure regulatory compliance and product performance excellence...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Elevate quality assurance in clinical development by ensuring GCP compliance, managing audits, and driving risk mitigation strategies. Collaborate with cross-functional teams to enhance quality standa...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$160K - $190K *

Transform clinical quality assurance by providing senior oversight for GCP compliance, driving risk mitigation strategies, and ensuring regulatory readiness across global clinical development activiti...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Advance your career by providing expert support in resin chemistry for structural adhesives. Collaborate with R&D and customers to optimize formulations, ensuring compliance with industry standards wh...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$115K - $156K *

Pioneer advanced engineering solutions for combination products, ensuring compliance and efficiency in the development, commercialization, and manufacturing of drug delivery devices. Lead cross-functi...

Reposted 3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$115K - $156K *

Drive operational excellence as you oversee the lifecycle management of electrical systems, ensuring compliance and reliability while collaborating with teams to enhance plant performance and safety s...

Yesterday

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$159K - $197K *

Drive compliance excellence in clinical development by providing technical leadership and oversight in GCP, GVP, GLP, and GPP. Collaborate with cross-functional teams to ensure quality and readiness f...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$77K - $118K *

Join a team that's redefining electrical design by leading multi-disciplinary projects, utilizing advanced modeling software, and mentoring emerging talent to deliver innovative solutions in a collabo...

2 weeks ago

  •   8 - 10 years exp.  •   Technical Services

$110K - $130K *

Champion clinical study delivery by managing timelines, budgets, and communication among teams, ensuring compliance with regulations and fostering effective stakeholder collaboration throughout the pr...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$100K - $120K *

Pioneer manufacturing excellence by implementing automation solutions that enhance efficiency, quality, and profitability while leading capital projects and driving process improvements in a dynamic c...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$117K - $184K *

Transform data engineering and analytics to enhance technical operations and business performance. Collaborate across teams to improve data access and usability, delivering scalable solutions that sup...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$117K - $184K *

Lead the charge in enhancing data engineering and analytics to optimize technical operations and business performance. Collaborate across teams to deliver scalable solutions that improve data access a...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$130K - $155K *

Unlock potential by providing expert legal support in contract management, collaborating effectively with counsel and stakeholders to enhance contracting processes and ensure compliance in a fast-pace...

South San Francisco, CARemote

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$132K - $148K *

Join us to lead strategic marketing initiatives that drive demand generation and customer engagement in the life sciences sector. Leverage your scientific expertise and marketing skills to deliver imp...

3 days ago

  •   5 - 7 years exp.  •   Business Services

$114K - $153K *

Join a dynamic team driving innovation in cloud-based web services, enhancing product functionality and quality in a fast-paced environment. Collaborate with cross-functional teams to tackle complex e...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$81K - $119K *

Support surgical product growth by providing clinical expertise and training. Collaborate with sales and internal teams to enhance customer relationships and drive market success through effective com...

Field, ONIn-Person

2 days ago

  •   5 - 7 years exp.  •   Healthcare

$146K - $162K *

Drive program success in medical devices by managing projects from initiation to delivery, collaborating across functions, and ensuring customer satisfaction while adhering to compliance and quality s...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Business Services

$110K - $130K *

Elevate business growth by identifying opportunities, nurturing partnerships, and driving revenue expansion in the biotechnology and diagnostics sectors. Collaborate with cross-functional teams to exe...

1 month ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Drive quality improvement with suppliers, overseeing audits, qualifications, and corrective actions. Leverage technical expertise for effective problem-solving while collaborating cross-functionally t...

3 weeks ago

  •   Less than 5 years exp.  •   Business Services

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.