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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$114K - $210K *

Join a team that's dedicated to developing high-quality regulatory documents for global submissions. Lead cross-functional projects, mentor junior writers, and ensure compliance with industry standard...

Delaware, USRemote

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$80K - $95K *

Drive compliance and operational excellence in cargo operations, collaborating with government teams and partners to ensure adherence to contracts and performance metrics while managing documentation...

2 days ago

  •   Less than 5 years exp.  •   Transportation

$97K - $148K *

Shape quality management systems by leading audits and compliance initiatives in aerospace distribution. Collaborate with teams to enhance processes, ensure adherence to AS9100 standards, and foster a...

Today

  •   8 - 10 years exp.  •   Aerospace & Defense

$110K - $130K *

Elevate your career by advising project managers on contract strategies, ensuring effective execution and maximizing project revenues through risk identification and mitigation in a dynamic environmen...

1 week ago

  •   5 - 7 years exp.  •   Energy & Utilities

$120K - $145K *

Build and lead a dynamic Quality Systems team, driving the strategy and improvement of a scalable Quality Management System to ensure compliance and support innovative biotech operations from clinical...

4 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Deliver independent QA oversight for GxP computerized systems, ensuring compliance and quality across digital initiatives. Collaborate with cross-functional teams to enhance patient safety and product...

Yesterday

  •   5 - 7 years exp.  •   Staffing

$110K - $130K *

Innovate as a Senior Medical Writer, delivering high-quality regulatory documents while collaborating with cross-functional teams to ensure compliance and operational excellence in a remote setting...

North Carolina, USRemote

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $125K *

Drive success by managing the full subcontract lifecycle, ensuring compliance and collaboration with project teams to support federal, state, and local contracts in a dynamic environment...

Arlington, VARemote

Today

  •   8 - 10 years exp.  •   Technical Services

$117K - $176K *

Join a team that's dedicated to ensuring compliance and quality through effective document control and procedure governance. Collaborate cross-functionally to enhance operational accuracy and support...

Reposted 1 week ago

  •   5 - 7 years exp.  •   Aerospace & Defense

$81K - $112K *

Contribute to innovative packaging solutions for medical devices, ensuring compliance and functionality. Collaborate cross-functionally to enhance processes and drive continuous improvement in a fast...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$81K - $112K *

Lead the charge in developing and improving packaging systems for medical devices, ensuring compliance and functionality through collaboration and technical expertise. Drive continuous improvement ini...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$95K - $115K *

Elevate your career by leading a dynamic QA team, ensuring compliance with FDA GLP standards, and driving continuous improvement in preclinical safety and toxicology testing. Manage audits, inspection...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$110K - $130K *

Lead the charge in enhancing regulatory compliance through effective UAT management, translating requirements into actionable test cases, and ensuring data integrity across systems. Collaborate with s...

Yesterday

  •   5 - 7 years exp.  •   Staffing

$81K - $112K *

Join a team that's dedicated to enhancing packaging systems for medical devices. You'll lead projects, ensure compliance, and collaborate cross-functionally to drive innovation and continuous improvem...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$87K - $137K *

Join a team that's dedicated to optimizing manufacturing processes and ensuring compliance. Collaborate with cross-functional teams to drive continuous improvement and support critical projects in a f...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$81K - $112K *

Optimize packaging processes for medical devices by leading design, testing, and compliance initiatives. Collaborate cross-functionally to ensure quality and efficiency in packaging systems, driving c...

1 week ago

  •   5 - 7 years exp.  •   Healthcare

$130K - $170K *

Join us to lead the development and optimization of fermentation and downstream processing technologies, driving innovation from lab-scale to commercial production while collaborating with cross-funct...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$142K - $224K *

Lead the commercialization of biologics by driving process excellence, scale-up, and validation activities. Collaborate across teams to ensure quality and efficiency in drug product development, while...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $90K *

Elevate your career by driving compliance initiatives and enhancing regulatory controls. Collaborate with cross-functional teams to identify risks, implement solutions, and ensure adherence to legal s...

Yesterday

  •   5 - 7 years exp.  •   Finance & Insurance

$80K - $90K *

Empower your career by driving compliance initiatives and enhancing regulatory controls. Collaborate across teams to identify risks, recommend improvements, and ensure adherence to regulations while s...

Yesterday

  •   5 - 7 years exp.  •   Finance & Insurance

$95K - $181K *

Unlock potential by leading strategic contracting efforts for complex programs. Collaborate with stakeholders to drive proposal development, negotiations, and contract execution, ensuring compliance a...

Yesterday

  •   5 - 7 years exp.  •   Aerospace & Defense

$88K - $105K *

Advance your career by executing high-throughput assays and analytical delivery for biopharmaceutical development. Collaborate with cross-functional teams to generate data that drives candidate select...

1 week ago

  •   Less than 5 years exp.  •   Media

$95K - $115K *

Champion regulatory excellence by developing and evaluating policies that enhance food safety and inspection programs. Collaborate with stakeholders to ensure effective communication and alignment on...

Today

  •   Less than 5 years exp.  •   Education, Government & Non-Profit

$95K - $115K *

Champion regulatory policy development by analyzing data, drafting documents, and guiding stakeholders to enhance food safety and inspection programs. Collaborate with diverse teams to set priorities...

Today

  •   Less than 5 years exp.  •   Education, Government & Non-Profit

$153K - $199K *

Drive the negotiation and management of clinical trial agreements, ensuring compliance and collaboration across teams. This hands-on role requires expertise in clinical contracting and general agreeme...

3 weeks ago

  •   5 - 7 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.