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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$90K - $110K *

Join a dynamic team to support clinical market segments by providing expert on-site service for liquid chromatography and mass spectrometry products, ensuring compliance and customer satisfaction thro...

3 weeks ago

  •   Less than 5 years exp.  •   Consumer Technology

$200K - $225K *

Pioneer strategic regulatory leadership in advertising and promotion, ensuring compliance while enabling innovative product communications. Collaborate cross-functionally to guide promotional strategi...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$85K - $105K *

Transform the deal lifecycle by leading contract management and RFP responses, ensuring seamless collaboration across teams while enhancing operational efficiency and compliance. Drive the establishme...

Brampton, ONIn-Person

2 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$171K - $189K *

Drive clinical study operations by managing CROs, vendors, and budgets. Lead cross-functional collaboration to ensure compliance and quality deliverables while mentoring junior team members and enhanc...

1 week ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$133K - $213K *

Manage CMC regulatory strategies and execution for product development. Collaborate with cross-functional teams and engage with regulatory agencies to ensure compliance and timely submissions, while i...

1 week ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join a team that's dedicated to ensuring quality excellence through meticulous document control, product release oversight, and data analysis, while fostering a collaborative environment to drive cont...

3 weeks ago

  •   5 - 7 years exp.  •   Manufacturing & Automotive

$117K - $184K *

Drive innovation in drug delivery device technology by analyzing and improving mechanical testing methods. Collaborate with cross-functional teams to enhance product performance and ensure compliance...

5 days ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$94K - $129K *

Transform quality assurance by leading batch disposition and compliance efforts. Drive cross-functional collaboration to enhance operational effectiveness and ensure timely release of drug substances...

2 days ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$80K - $90K *

Optimize administrative operations by providing comprehensive support to leadership and teams, managing tasks, documentation, and communications for effective program execution in a dynamic defense en...

2 weeks ago

  •   11 - 15 years exp.  •   Technical Services

$146K - $182K *

Partner with us to lead global regulatory submissions and document management. Drive operational excellence and compliance while collaborating with cross-functional teams to enhance processes and syst...

3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$146K - $182K *

Transform regulatory operations by leading global submissions and document management. Collaborate with cross-functional teams to ensure compliance and efficiency while driving continuous improvement...

3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$146K - $182K *

Advance your career by leading global regulatory submissions and document management. Drive compliance and efficiency while collaborating with cross-functional teams to enhance operational processes a...

3 days ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$80K - $95K *

Join a team that's dedicated to enhancing Quality Management Systems through effective administration, validation, and continuous improvement, ensuring compliance and operational excellence across var...

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$80K - $100K *

Play a key role in executing complex engineering projects in a manufacturing environment, ensuring compliance with regulations while enhancing productivity, safety, and efficiency through collaboratio...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$114K - $162K *

Lead the charge in strategic procurement for electronics-intensive offers, collaborating with R&D and product teams to shape sourcing strategies, manage supplier relationships, and drive data-driven d...

Montreal, QCIn-Person

Yesterday

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$114K - $162K *

Lead the charge in strategic procurement for electronics-intensive offers, collaborating with cross-functional teams to shape product design and sourcing strategies while managing supplier relationshi...

Calgary, ABIn-Person

Yesterday

  •   Less than 5 years exp.  •   Manufacturing & Automotive

$97K - $140K *

Unlock compliance excellence by guiding the movement of controlled goods. Collaborate with cross-functional teams to ensure adherence to U.S. export regulations while supporting business growth and op...

2 weeks ago

  •   Less than 5 years exp.  •   Aerospace & Defense

$120K - $145K *

Innovate in aseptic filling engineering by leading system design, optimization, and compliance. Collaborate across teams to enhance drug manufacturing, ensuring quality and efficiency in a dynamic env...

Reposted 2 weeks ago

  •   8 - 10 years exp.  •   Pharmaceuticals & Biotech

$129K - $207K *

Lead the charge in post-market quality initiatives, ensuring compliance and driving improvements across global operations. Collaborate with cross-functional teams to enhance product safety and effecti...

3 weeks ago

  •   5 - 7 years exp.  •   Healthcare

$110K - $130K *

Deliver comprehensive oversight and guidance for clinical trial monitoring, ensuring compliance and quality. Collaborate with cross-functional teams to address site issues, enhance recruitment, and ma...

Boston, MARemote

2 weeks ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$163K - $239K *

Lead and transform the Global Quality Auditing teams, ensuring compliance and quality in clinical development and regulatory affairs. Drive strategic initiatives, manage global audits, and foster coll...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$95K - $115K *

Join a team that's driving innovation in sterile pharmaceutical manufacturing. Leverage your expertise in process engineering to support tech transfers, validate processes, and ensure compliance with...

2 weeks ago

  •   5 - 7 years exp.  •   Pharmaceuticals & Biotech

$90K - $175K *

Elevate clinical research by ensuring compliance and data integrity through effective site management and monitoring. Collaborate with teams to drive successful trial execution and uphold regulatory s...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$90K - $175K *

Optimize clinical trial execution by monitoring sites, ensuring compliance with protocols, and enhancing data integrity. Collaborate with teams to drive recruitment strategies and maintain regulatory...

1 week ago

  •   Less than 5 years exp.  •   Pharmaceuticals & Biotech

$90K - $175K *

Elevate your career with a pivotal role in clinical research, ensuring compliance and data integrity while managing site operations and collaborating with cross-functional teams to drive successful tr...

1 week ago

  •   Less than 5 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.