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 Quality Management Systems Specialist
$97K - $148K *
Lead the charge in enhancing aerospace quality management systems, ensuring compliance with AS9100 and AS9120 standards. Collaborate with teams to drive continuous improvement, audit processes, and fo...
Yesterday
Senior Quality Management Systems Specialist
$97K - $148K *
Drive excellence in aerospace quality management systems, ensuring compliance with AS9100 and AS9120 standards. Collaborate with teams to enhance quality processes, conduct audits, and foster a cultur...
Yesterday
Quality Assurance, Post Market Specialist
$83K - $139K *
Shape the future of patient safety by supporting post-market surveillance efforts and ensuring compliance with global regulatory standards. Collaborate with cross-functional teams to analyze product c...
Reposted 2 days ago
Senior Product Development Engineer - Medical Devices
$110K - $130K *
Innovate in medical device development by leading complex projects from concept to manufacturing. Collaborate with cross-functional teams to ensure high-quality outcomes while mentoring junior enginee...
3 weeks ago
Associate Director, Regulatory Project Management
$136K - $220K *
Unlock project management excellence in Global Regulatory Affairs, driving timelines and compliance for drug submissions. Collaborate cross-functionally to ensure accurate documentation and effective...
Reposted 1 week ago
Senior Requirements Analyst, USCG C5I
$97K - $107K *
Advance your career by leading requirements development and management for critical C5I systems. Collaborate with government teams to ensure alignment with mission needs while supervising a dedicated...
Reposted today
Validation Engineering Specialist
$80K - $95K *
Bring your expertise to our dynamic team as you enhance compliance and validation processes, coordinating key projects that shape our manufacturing quality standards and ensure adherence to regulatory...
3 weeks ago
Specialist III, QA Sterile Manufacturing
$84K - $126K *
Drive quality assurance excellence in sterile manufacturing, ensuring compliance with GMP, ISO, and FDA standards while overseeing production operations and supporting the release of pharmaceutical pr...
2 weeks ago
$125K - $175K *
Manage quality assurance for aerospace electronics, leading AS9100 compliance, inspections, and continuous improvement initiatives. Collaborate across teams to enhance product quality and customer sat...
1 week ago
$125K - $175K *
Lead the charge in quality management for aerospace and defense electronics, driving product conformity and customer satisfaction while collaborating across teams to enhance performance and implement...
1 week ago
Global Regulatory Affairs Lead
$125K - $150K *
Join a team that's shaping global regulatory strategies for microbial products, ensuring compliance across regions to support market entry and growth. This role involves strategic oversight, internati...
Reposted 1 week ago
$95K - $115K *
Lead the charge in enforcing NRC policies for licensed facilities, ensuring compliance through evaluation, documentation, and expert testimony. Collaborate with various stakeholders to uphold safety s...
Yesterday
Sr. Specialist, Quality Assurance
$95K - $115K *
Transform quality assurance processes by leading project-wide initiatives, ensuring compliance, and driving continuous improvement. Collaborate with teams to enhance quality management and promote awa...
3 weeks ago
$61K - $122K *
Champion supplier quality initiatives by assessing performance, ensuring compliance with regulations, and driving corrective actions. Collaborate with teams to maintain quality standards and enhance s...
Reposted 3 weeks ago
Senior Research Compliance Specialist - Export Control
$80K - $95K *
Drive compliance excellence by ensuring adherence to research regulations, conducting audits, and fostering a culture of responsible research. Collaborate with faculty and staff to enhance compliance...
1 week ago
Manager Regulatory Affairs, Global Regulatory Strategy US & Canada - Hybrid
$110K - $130K *
Shape the future of regulatory strategy by managing US and Canada submissions, ensuring compliance, and collaborating with cross-functional teams to drive product commercialization and regulatory exce...
2 days ago
Sr. Regulatory Compliance Engineer
$122K - $227K *
Unlock potential by leading compliance initiatives, monitoring regulations, and guiding R&D teams to ensure product adherence to safety and quality standards while managing audits and customer inquiri...
2 days ago
Sr. Regulatory Compliance Engineer
$122K - $227K *
Champion compliance excellence by leading projects, monitoring regulations, and supporting R&D teams to ensure product adherence to safety and quality standards. Drive operational efficiency and maint...
2 days ago
Sr. Regulatory Compliance Engineer
$122K - $227K *
Champion compliance excellence by leading projects, monitoring regulations, and supporting R&D teams to ensure product adherence to safety and quality standards. Collaborate with internal and external...
2 days ago
Sr. Regulatory Compliance Engineer
$122K - $227K *
Champion compliance initiatives by leading projects, monitoring regulations, and supporting R&D teams to ensure product adherence to safety and quality standards while maintaining a comprehensive know...
2 days ago
$108K - $201K *
Drive compliance and risk management initiatives across IT/OT services, ensuring adherence to security standards and regulatory requirements. Collaborate with teams to enhance governance programs and...
1 week ago
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
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.