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 Applications Specialist - East Coast
$83K - $95K *
Drive validation of Chemistry and Immunoassay instruments, ensuring compliance with specifications and regulatory standards. Collaborate with customers and internal teams to provide training and suppo...
1 week ago
Senior Field Applications Specialist - East Coast
$83K - $95K *
Lead the charge in validating Chemistry and Immunoassay instruments, ensuring compliance with specifications and regulatory standards while providing training and support to customers in the Mid-Atlan...
1 week ago
Senior Subcontracts Administrator
$80K - $125K *
Manage the full subcontract lifecycle, ensuring compliance and effective collaboration with stakeholders to mitigate risks and facilitate project success in a dynamic environment...
Reposted today
Senior Specialist, Procurement
$96K - $151K *
Unlock your potential by driving strategic supplier management and procurement initiatives. Collaborate across divisions to enhance supply chain resilience, optimize costs, and support innovative prod...
Yesterday
Senior Specialist, Procurement
$96K - $151K *
Optimize supplier management strategies to enhance supply chain resilience, drive cost improvements, and support product development initiatives. Collaborate across teams to ensure effective sourcing...
Yesterday
$121K - $193K *
Lead the charge in driving EU MDR compliance initiatives by managing cross-functional programs, ensuring timely delivery of regulatory milestones while optimizing resources and stakeholder engagement...
3 days ago
$135K - $216K *
Lead and optimize EU MDR compliance initiatives, managing cross-functional programs to ensure timely delivery of regulatory milestones while aligning with business objectives and proactively addressin...
3 days ago
Regulatory Affairs Operations Specialist – Vascular (on-site)
$61K - $122K *
Optimize regulatory operations by ensuring compliance with evolving standards, managing audit readiness, and collaborating with cross-functional teams to maintain an effective quality system in a dyna...
1 week ago
$110K - $130K *
Champion quality excellence by leading the development and implementation of robust quality systems. Drive continuous improvement and ensure compliance with safety and regulatory standards while foste...
1 week ago
Senior Medical & Clinical Affairs (MACA) Operations Specialist
$76K - $110K *
Lead operational excellence in Medical and Clinical Affairs, managing grants, coordinating cross-functional teams, and ensuring efficient program execution to enhance healthcare outcomes and support s...
2 weeks ago
Senior Medical & Clinical Affairs (MACA) Operations Specialist
$76K - $110K *
Champion operational excellence in Medical and Clinical Affairs, overseeing grant management, project coordination, and cross-functional collaboration to drive strategic initiatives and ensure high-qu...
2 weeks ago
$145K - $234K *
Grow your career with us as you support risk management practices, assess technology and cybersecurity risks, and enhance governance reporting in a dynamic, regulated environment. Collaborate cross-fu...
2 weeks ago
Senior Analyst, R&D Quality Data Analytics
$89K - $141K *
Champion data-driven insights by leading quality analytics initiatives, ensuring compliance and operational excellence in R&D. Collaborate with stakeholders to design impactful dashboards and enhance...
Reposted 4 days ago
Vice President, Head of Regulatory Affairs
$272K - $409K *
Pioneer regulatory excellence in medical devices. Lead a global team to drive product approvals, ensure compliance, and shape strategic direction for the Radiology portfolio, optimizing value and fost...
2 weeks ago
Senior QC Scientist - Program Management
$110K - $120K *
Join a dynamic team as a Senior QC Scientist, where you'll coordinate Quality Control activities, ensuring compliance and timely testing across projects. Collaborate with cross-functional teams to uph...
1 week ago
Specialist, Global Analytical Instrument Validation (On-site)
$96K - $151K *
Empower your career by joining a dynamic team focused on validating cutting-edge analytical instruments in a GMP environment. Collaborate globally to ensure compliance and drive operational excellence...
1 week ago
Sr. Clinical Research Associate
$110K - $125K *
Lead the charge in overseeing clinical studies to enhance organ preservation through innovative research and management strategies, ensuring compliance and data integrity across multiple protocols and...
Reposted 4 weeks ago
$95K - $115K *
Lead the charge in developing innovative manufacturing systems for medical devices, ensuring compliance with industry regulations while optimizing processes from pilot to full-scale production...
2 weeks ago
$95K - $115K *
Join a team that's dedicated to advancing eye health by leading the development of innovative inspection systems for automated medical-device manufacturing, ensuring quality and reliability in product...
2 days ago
Senior Account Manager, Med Affairs
$90K - $105K *
Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...
Reposted 1 week ago
$109K - $174K *
Lead the charge in developing next-gen surgical navigation systems for orthopaedics. Collaborate across teams to ensure clear, traceable requirements and deliver safe, reliable solutions that enhance...
Yesterday
$109K - $174K *
Shape the future of surgical navigation systems in orthopaedics. As a Senior Systems Engineer, you'll drive system requirements, risk analysis, and interface definitions, collaborating with cross-func...
Yesterday
Senior Quality Systems Auditor
$126K - $138K *
Lead internal quality audits to ensure compliance with ISO 13485 and FDA regulations. Play a key role in improving QMS processes, managing audit findings, and supporting certification efforts within t...
Reposted 4 weeks ago
Sr. Global Trade & Operations Compliance Specialist
$80K - $95K *
Champion end-to-end trade compliance and global operations for regulated supply chains. Drive import/export processes, ensuring adherence to standards while collaborating with cross-functional teams t...
2 weeks ago
Senior Manager, Quality Assurance
$120K - $145K *
Lead the charge in ensuring quality assurance for transport and packaging validation, collaborating with cross-functional teams to uphold compliance and readiness for commercial drug products while ma...
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.