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.
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.
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.
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.
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.
Senior Field Service Specialist
$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
Director Regulatory Promotional Compliance & Scientific Messaging
$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
Senior Specialist, Contracts & Legal Operations
$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...
2 weeks ago
$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
Senior Manager, Global CMC Regulatory Affairs
$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
$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
Sr. Scientist, Drug/Device Combo Products (Onsite)
$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
$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
Senior Administrative Assistant
$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
Associate Director, Regulatory Operations
$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
Associate Director, Regulatory Operations
$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
Associate Director, Regulatory Operations
$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
Quality Applications Specialist
$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
Senior Project Engineer - Fit & Finish
$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
Senior Specialist, Offer Lifecycle Procurement
$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...
Yesterday
Senior Specialist, Offer Lifecycle Procurement
$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...
Yesterday
Senior Trade Compliance Specialist (R6250)
$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
Sr. Princ. Process Engineer - DP Aseptic Biotherapeutic Filling Equipment
$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
Staff Specialist, Post Market Quality
$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
Clinical Research Associate- Oncology Monitoring Experience Required
$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...
2 weeks ago
Sr. Director- GQA Global Medical Regulatory Safety
$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
Sr. Process Engineer - MSAT, GMP, Tech Transfer
$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
Clinical Research Associate, Early Clinical Development
$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
Clinical Research Associate, Early Clinical Development
$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
Clinical Research Associate, Early Clinical Development
$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
What does a senior regulatory affairs specialist do?
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?
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?
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?
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?
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.