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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$220K - $275K *

Elevate your career by leading global CMC regulatory strategies for biologics. Collaborate with cross-functional teams, ensure compliance, and drive successful product development while mentoring a hi...

United StatesRemote

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$95K - $153K *

Champion quality systems and compliance in a global organization, ensuring regulatory readiness and customer support. Collaborate with stakeholders to maintain documentation and resolve complex qualit...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$92K - $176K *

Unlock your potential by leading QA validation strategies for laboratory and manufacturing equipment. Drive compliance, manage budgets, and collaborate with teams to ensure operational excellence in a...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$114K - $212K *

Transform quality assurance processes by embedding risk-based controls and driving operational excellence in manufacturing, packaging, and warehouse operations, ensuring compliance with global standar...

Today

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$86K - $165K *

Join us in driving supplier quality excellence across aerospace and defense. In this role, you'll lead supplier assessments, resolve complex quality issues, and collaborate with cross-functional teams...

Minnesota, USRemote

Yesterday

  •   5 - 7 years exp.  •   Aerospace & Defense

$150K - $180K *

Shape global Regulatory CMC strategies for gene therapy products, ensuring compliance and successful submissions. Collaborate with cross-functional teams to drive projects from clinical trials to comm...

2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $110K *

Join a team that's dedicated to enhancing quality systems and compliance. Collaborate with cross-functional teams to implement and maintain quality management processes, ensuring adherence to industry...

Yesterday

  •   5 - 7 years exp.  •   Aerospace & Defense

$114K - $212K *

Unlock your potential as a Principal QA Specialist, driving quality oversight in manufacturing processes. Collaborate with diverse teams to ensure compliance and operational excellence, embedding qual...

Today

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$65K - $129K *

Lead the charge in developing competitive proposals and client services, enhancing operational excellence across clinical research programs. Collaborate with global teams to ensure high-quality submis...

Texas, USRemote

Reposted 2 days ago

  •   Less than 5 years exp.  •   Healthcare

$105K - $120K *

Engineer high-quality analytical solutions in a dynamic QC environment. Leverage your expertise in molecular biology and protein chemistry to support GMP manufacturing and mentor laboratory staff whil...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$190K - $285K *

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

United StatesRemote

Reposted 3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$93K *

Champion regulatory compliance and risk management within a dynamic tech environment, ensuring alignment with industry standards and enhancing operational effectiveness through diligent analysis, asse...

Victoria, BCIn-Person

3 weeks ago

  •   Less than 5 years exp.  •   Information Technology

$67K - $100K *

Unlock potential by driving regulatory compliance and product safety initiatives. Collaborate with cross-functional teams to develop Safety Data Sheets and labels, ensuring adherence to global standar...

2 weeks ago

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$149K - $248K *

Shape regulatory strategies across Latin America! Lead compliance initiatives, engage with regulatory bodies, and steer a high-performing team to drive innovation and improve health outcomes in the me...

Florida, USRemote

Reposted 2 weeks ago

  •   11 - 15 years exp.  •   Healthcare

$94K - $128K *

Lead engineering initiatives to enhance equipment reliability and efficiency in biopharma manufacturing. Collaborate cross-functionally to optimize processes and ensure compliance while mentoring team...

Reposted 4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Oversee the implementation and continuous improvement of an enterprise Configuration Management Program, ensuring compliance and operational excellence across technology environments while driving rem...

Yesterday

  •   5 - 7 years exp.  •   Staffing

$130K - $150K *

Lead impactful QA/RA initiatives to enhance compliance and quality systems for medical device clients. Drive innovative strategies using AI technology to shape the future of regulatory affairs and ens...

Reposted 4 weeks ago

  •   Less than 5 years exp.  •   Healthcare

$110K - $130K *

Drive clinical trial success by managing operations, monitoring, and site relationships for diverse studies. Collaborate cross-functionally to ensure compliance, data integrity, and high-quality outco...

Yesterday

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Engage with government and regulatory bodies to shape automotive safety and technology policies. Lead communications, manage submissions, and foster collaboration across teams to ensure compliance and...

2 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$95K - $115K *

Help us enhance supplier quality by leading assessments, audits, and performance improvements. Collaborate with cross-functional teams to ensure compliance and drive measurable enhancements in supplie...

Yesterday

  •   5 - 7 years exp.  •   Enterprise Technology

$165K - $243K *

Join us to lead enterprise-level proposal operations, overseeing complex, multi-volume proposals for large-scale acquisitions. Collaborate with cross-functional teams to ensure compliant, competitive...

1 week ago

  •   11 - 15 years exp.  •   Aerospace & Defense

$80K - $95K *

Elevate quality assurance standards by monitoring and controlling procurement and production processes for government contracts, ensuring compliance and effectiveness in aviation operations...

3 days ago

  •   11 - 15 years exp.  •   Aerospace & Defense

$102K *

Unlock your potential by leading Root Cause Investigation and CAPA initiatives across R&D. Collaborate with cross-functional teams to resolve complex issues, enhance quality, and drive data-led soluti...

Mississauga, ONIn-Person

2 days ago

  •   Less than 5 years exp.  •   Information Technology

$95K - $115K *

Shape the future of agricultural innovation by overseeing regulatory compliance and product registrations. Collaborate with cross-functional teams to ensure market access and navigate complex regulato...

4 days ago

  •   5 - 7 years exp.  •   Food & Beverages

$134K - $219K *

Optimize data quality by leading monitoring operations, ensuring compliance with standards, and providing actionable insights for decision-making. Collaborate with cross-functional teams to enhance da...

4 days 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.