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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$102K - $154K *

Lead the charge in shaping EHS strategy and culture across operations, driving safety initiatives, incident investigations, and compliance support while collaborating with diverse teams to ensure a pr...

2 weeks ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$110K - $140K *

Pioneer GxP compliance in digital quality management, ensuring software and AI products meet regulatory standards. Collaborate with stakeholders to enhance quality processes and support audits, drivin...

United StatesRemote

1 week ago

  •   Less than 5 years exp.  •   Healthcare

$88K - $154K *

Optimize regulatory compliance and permitting processes for projects, ensuring adherence to local, state, and federal requirements. Collaborate with stakeholders to track permits, approvals, and incen...

1 week ago

  •   8 - 10 years exp.  •   Real Estate & Construction

$88K - $154K *

Join a team that's dedicated to ensuring regulatory compliance and efficient permitting processes. In this role, you'll manage permit tracking, monitor compliance, and support incentive-related activi...

1 week ago

  •   8 - 10 years exp.  •   Real Estate & Construction

$88K - $105K *

Lead the charge in quality assurance by directing a team, ensuring compliance with industry standards, and implementing process improvements to enhance contractor performance and product quality for m...

Today

  •   Less than 5 years exp.  •   Aerospace & Defense

$94K - $144K *

Elevate quality assurance standards by leading a team to ensure compliance with complex manufacturing requirements, implementing process improvements, and providing technical guidance to stakeholders...

Yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$90K - $138K *

Join a dynamic team to lead quality assurance efforts, ensuring compliance with industry standards and enhancing contractor performance through continuous improvement initiatives. Drive technical guid...

Yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$94K - $144K *

Shape the future of quality assurance by leading a team to enhance compliance and operational excellence in defense contracting, ensuring adherence to industry standards and driving continuous improve...

Yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$95K - $146K *

Unlock potential by leading a team of quality assurance professionals, ensuring compliance with industry standards, and driving continuous improvement in defense contracting processes to enhance produ...

Yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$91K - $140K *

Lead the charge in quality assurance by guiding a skilled team, ensuring compliance with industry standards, and driving continuous improvement in defense contracting processes to enhance operational...

Yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$85K - $100K *

Transform your career by leading a team of quality assurance professionals, ensuring compliance with industry standards, and driving continuous improvement in defense contracting processes. Play a piv...

1 week ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$144K - $208K *

Join a team that's dedicated to ensuring top-tier quality in semiconductor and micro-display materials. You'll lead supplier assessments, enforce quality standards, and collaborate with cross-function...

1 week ago

  •   5 - 7 years exp.  •   Enterprise Technology

$100K - $120K *

Join a dynamic team to design and oversee quality assurance for AI-driven platforms. Leverage your expertise in automation and compliance to ensure reliable, high-quality software solutions while coll...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Join us to design and oversee the quality assurance framework for our AI platform. You'll implement automated testing, ensure compliance, and collaborate with cross-functional teams to maintain high-q...

Overland Park, KSRemote

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Transform military systems design and development by leveraging your expertise in electrical engineering. Collaborate on cutting-edge projects involving radar, RF systems, and advanced circuitry to en...

4 days ago

  •   5 - 7 years exp.  •   Information Technology

$145K - $160K *

Lead the charge in shaping global CMC regulatory strategies, driving lifecycle management initiatives, and providing expert guidance to cross-functional teams to ensure compliance and success across m...

4 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Champion compliance excellence by enhancing product complaint processes while leading cross-functional teams to ensure accurate handling of medical reports, investigations, and adherence to global reg...

4 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Join a team that's committed to quality and compliance in product complaint handling. You will oversee end-to-end processes, ensuring accuracy and adherence to regulations while collaborating with cro...

1 month ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$93K - $128K *

Optimize research efficiency by managing chemical and biological samples. Collaborate with cross-functional teams to ensure sample integrity, accurate tracking, and timely distribution in a fast-paced...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$132K - $198K *

Join a team that's redefining compliance in SaaS security. As a Principal GCO High Compliance Systems Advisor, you'll lead FedRAMP authorization, manage technical controls, and ensure audit readiness...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$132K - $198K *

Shape high-compliance certification programs by leading FedRAMP authorization, managing technical controls, and ensuring audit readiness across multi-jurisdictional SaaS security operations. Collabora...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$132K - $198K *

Optimize high-compliance certification programs by leading FedRAMP authorization, managing technical controls, and collaborating with cross-functional teams to ensure audit readiness and regulatory co...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $100K *

Join a dynamic team to oversee analytical process development of proteins, optimizing in-process assays and enhancing lab efficiencies while delivering data-driven support and insights to stakeholders...

3 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$98K - $148K *

Optimize quality assurance processes by leading investigations, managing nonconforming materials, and collaborating with vendors and engineering teams to enhance product quality and compliance with in...

Reposted 1 week ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$85K - $120K *

Join a dynamic team to manage legal processes, ensuring compliance and efficiency. You'll streamline operations, support attorneys, and leverage technology to enhance workflows, all while maintaining...

2 weeks ago

  •   Less than 5 years exp.  •   Finance & Insurance

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.