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 Sales Specialist – High-Plex Sequencing
$140K - $180K *
Elevate your career by driving market growth in High-Plex Sequencing. Collaborate with research and clinical customers to develop strategies, optimize workflows, and establish yourself as a trusted te...
3 weeks ago
Senior Sales Specialist – High-Plex Sequencing
$140K - $180K *
Drive market growth as a High-Plex Sequencing Sales Specialist, leveraging your NGS expertise to shape strategies, build relationships, and influence adoption of innovative library prep solutions acro...
3 weeks ago
Senior Clinical Research Associate
$110K - $138K *
Transform clinical research by leading site management for phase II-IV trials. Collaborate with a dedicated team to ensure compliance, efficiency, and quality in Dermatology & Rare Disease studies whi...
1 week ago
Senior Clinical Research Associate
$95K - $115K *
Champion clinical trial excellence by overseeing monitoring activities, ensuring compliance with protocols and regulations, and fostering collaboration across teams to drive successful outcomes and co...
4 days ago
Senior Clinical Research Associate
$100K - $120K *
Lead clinical trial monitoring efforts, ensuring compliance with protocols and regulations while fostering collaboration across teams to enhance data integrity and site performance...
5 days ago
Senior Clinical Research Associate
$80K - $95K *
Join a team that's dedicated to advancing clinical research by monitoring trials, ensuring compliance with protocols and regulations, and contributing to the success of innovative healthcare solutions...
6 days ago
Senior Clinical Research Associate
$108K - $135K *
Lead the charge in clinical research by monitoring trials, ensuring compliance with protocols and regulations, and enhancing patient safety. Collaborate with teams to drive successful outcomes in drug...
1 week ago
Senior Clinical Research Associate
$108K - $135K *
Elevate your career by ensuring clinical trials meet regulatory standards and protocols. As a key player, you'll monitor studies, collaborate with teams, and contribute to life-saving research in a dy...
1 week ago
$119K - $126K *
Pioneer compliance and certification processes for airborne systems, ensuring adherence to airworthiness standards. Collaborate with cross-functional teams to deliver comprehensive certification docum...
2 weeks ago
Director, Contract Testing Laboratories Quality Oversight
$173K - $272K *
Lead the charge in ensuring quality oversight for contract testing laboratories globally, implementing policies and managing performance to meet regulatory standards while safeguarding patient safety...
Yesterday
Senior Electrical Physical Wiring Designer 1 - Nuclear Power
$77K - $118K *
Elevate your drafting career by collaborating in a dynamic team, utilizing advanced CAD tools, and gaining hands-on experience in 3D design. Contribute to innovative projects that shape the future of...
1 week ago
Claims Regulatory Compliance Manager
$95K - $115K *
Lead compliance initiatives within the Claims department, ensuring adherence to laws and regulations. Monitor regulatory changes, implement policies, conduct audits, and serve as the primary liaison w...
2 weeks ago
Claims Regulatory Compliance Manager
$95K - $115K *
Drive compliance excellence in the Claims department by ensuring adherence to laws and regulations. Oversee audits, implement policies, and serve as the liaison with regulatory bodies to maintain high...
2 weeks ago
Claims Regulatory Compliance Manager
$95K - $115K *
Join a team that's dedicated to ensuring compliance within the Claims department. You'll monitor regulations, implement policies, conduct audits, and liaise with regulatory authorities to uphold indus...
2 weeks ago
Claims Regulatory Compliance Manager
$95K - $115K *
Grow your career with a pivotal role ensuring compliance in the Claims department. Monitor regulations, implement policies, conduct audits, and liaise with authorities to uphold industry standards and...
2 weeks ago
$71K - $103K *
Join a team that's dedicated to advancing protein purification processes and diagnostics. Collaborate with scientists to develop robust systems, troubleshoot challenges, and present findings that driv...
3 weeks ago
$70K - $99K *
Analyze and interpret complex materials testing data to support product development and quality decisions. Collaborate with cross-functional teams to enhance testing methods and drive materials innova...
Reposted 2 weeks ago
Senior Records and Information Management Specialist
$95K - $115K *
Empower compliance by leading initiatives in Data, Records, and Information Management. Oversee projects ensuring adherence to federal laws, analyze program effectiveness, and communicate progress to...
6 days ago
Regulatory and Compliance Specialist
$66K - $105K *
Contribute to food safety and quality initiatives by supporting compliance programs, maintaining SQF certification, and collaborating with cross-functional teams to ensure regulatory adherence and con...
3 days ago
Supervisory Quality Assurance Specialist
$90K - $138K *
Drive excellence in quality assurance by leading a team, ensuring compliance with industry standards, and implementing process improvements for defense contractors. Engage with senior leaders to resol...
2 days ago
Supervisory Quality Assurance Specialist
$90K - $138K *
Empower a team of quality assurance professionals, ensuring compliance with industry standards and enhancing contractor performance through continuous improvement and technical guidance in a high-stak...
2 days ago
Supervisory Quality Assurance Specialist
$91K - $139K *
Lead a team of quality assurance professionals, ensuring compliance with industry standards and enhancing contractor performance through continuous improvement initiatives. Collaborate with senior lea...
2 days ago
Supervisory Quality Assurance Specialist
$94K - $144K *
Take ownership of quality assurance leadership, guiding teams to ensure compliance with industry standards and enhancing contractor performance through continuous improvement initiatives. Engage with...
2 days ago
$108K - $153K *
Innovate packaging solutions by designing and validating complex systems for product launches. Collaborate with cross-functional teams to enhance packaging technologies and ensure compliance with indu...
6 days ago
Senior Specialist, QA Shop Floor M-F, Cell Therapy
$89K - $108K *
Join a team that's dedicated to ensuring quality in manufacturing and operations. Oversee compliance with cGMP standards, engage with cross-functional teams, and drive improvements through data analys...
2 weeks 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.