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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$86K - $165K *

Join a dynamic team as you lead the management of nonconforming materials, collaborating with cross-functional teams to enhance quality assurance processes and drive continuous improvement in a fast-p...

3 days ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$105K - $140K *

Lead the charge in monitoring clinical study sites, ensuring data integrity and patient safety while collaborating with diverse teams to enhance study delivery and compliance with regulatory standards...

United StatesRemote

Reposted yesterday

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$174K - $324K *

Elevate clinical quality compliance by leading strategic initiatives, driving partnerships, and ensuring adherence to global regulations in early clinical development, while fostering a proactive qual...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Empower our teams by leading technical clarifications and resolving complex product issues. Collaborate across engineering and operations to ensure accurate order execution and enhance customer satisf...

2 days ago

  •   8 - 10 years exp.  •   Business Services

$145K - $170K *

Shape the quality management landscape by driving compliance, continuous improvement, and operational excellence while ensuring adherence to regulatory standards and enhancing site performance across...

Reposted 3 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$225K - $275K *

Lead a dynamic quality organization, ensuring compliance and excellence across diverse aerospace products. Drive quality strategy, build relationships with government and prime customers, and foster a...

1 week ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$80K - $95K *

Support project management by coordinating study documentation, mentoring team members, and ensuring compliance. Leverage expertise in clinical research to enhance study start-up and execution, while...

United StatesRemote

4 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$95K - $114K *

Join us to drive quality excellence in a new membrane manufacturing operation. Collaborate with cross-functional teams to implement robust quality controls, ensuring a capable and customer-ready produ...

Today

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$95K - $114K *

Drive quality excellence in semiconductor manufacturing by enhancing process controls and quality systems. Collaborate across operations to ensure product integrity and compliance while leading invest...

4 days ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$95K - $115K *

Transform quality assurance practices by leading cross-functional teams to ensure compliance, enhance processes, and uphold product safety while fostering a culture of continuous improvement and opera...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$175K - $200K *

Create impactful regulatory strategies that advance global product development, ensuring compliance with medical device regulations and driving business expansion while collaborating cross-functionall...

Reposted 1 week ago

  •   8 - 10 years exp.  •   Manufacturing & Automotive

$119K - $173K *

Transform change control processes by leading a team to enhance governance, improve decision-making, and ensure compliance in a regulated environment, driving quality and efficiency across the organiz...

1 week ago

  •   8 - 10 years exp.  •   Food & Beverages

$95K - $115K *

Engineer impactful design quality solutions in medical devices. Drive product lifecycle compliance and validation efforts, ensuring safety and performance through collaboration with cross-functional t...

Reposted 4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $145K *

Lead end-to-end quality investigations and drive improvements across product families. Oversee risk management, collaborate cross-functionally, and ensure compliance with industry standards while ment...

3 weeks ago

  •   8 - 10 years exp.  •   Healthcare

$86K - $165K *

Drive strategic sourcing and supplier management for aerospace hardware, optimizing costs and ensuring compliance. Collaborate with cross-functional teams to influence design and enhance supply chain...

Connecticut, USRemote

Yesterday

  •   Less than 5 years exp.  •   Aerospace & Defense

$93K - $120K *

Help us enhance quality compliance by conducting risk-based audits and collaborating with stakeholders to ensure adherence to regulatory standards and continuous improvement in our Quality Management...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$93K - $120K *

Contribute to quality assurance by conducting risk-based audits, ensuring compliance with ISO 13485 and GxP standards. Collaborate with stakeholders to enhance audit programs and support continuous im...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$93K - $117K *

Shape the future of operational technology by leading system design, implementation, and support in a GMP-regulated environment. Collaborate with cross-functional teams to enhance manufacturing and qu...

3 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Join us to provide expert application support for cutting-edge separation technologies. Engage with customers throughout their journey, ensuring successful implementation and adoption while collaborat...

RemoteRemote

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$120K - $150K *

Help us transform defense production by enhancing supplier capabilities and manufacturing readiness. Leverage your expertise to drive improvements, implement recovery plans, and ensure quality outcome...

3 days ago

  •   8 - 10 years exp.  •   Aerospace & Defense

$145K - $160K *

Drive the development of global clinical regulatory strategies and ensure compliance with Health Authority requirements for investigational and marketed products, while preparing essential regulatory...

5 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$108K - $153K *

Empower quality excellence by applying engineering principles to sustain compliant manufacturing processes and resolve complex product quality issues, ensuring continuous improvement in a regulated me...

4 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$117K - $185K *

Transform supplier quality processes and drive improvements through collaboration, audits, and partnership development, ensuring compliance with industry standards while fostering a culture of excelle...

3 weeks ago

  •   5 - 7 years exp.  •   Telecommunications & Hardware

$117K - $185K *

Drive supplier quality improvements and establish partnerships as you analyze and resolve issues. Collaborate with teams, enhance processes for onboarding and managing suppliers, and ensure adherence...

3 weeks ago

  •   5 - 7 years exp.  •   Telecommunications & Hardware

$88K - $130K *

Empower your career by leveraging your medical writing expertise to create impactful scientific publications. Collaborate with cross-functional teams to ensure high-quality, accurate documents that ad...

2 weeks ago

  •   Less than 5 years exp.  •   Healthcare

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.