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 Manager Regulatory Affairs Advertising and Promotion
$122K - $176K *
Strategize and lead regulatory strategies for advertising and promotions, ensuring compliance and effectiveness. Work cross-functionally to maximize product impact and navigate complex medical environ...
Reposted 2 weeks ago
Specialist III – Quality Assurance, Systems
$95K - $115K *
Champion quality assurance initiatives by managing complex deviations and CAPA systems. Collaborate with stakeholders to enhance compliance and operational excellence while driving process improvement...
Yesterday
Field Quality Compliance Specialist
$79K - $93K *
Elevate quality standards in construction by implementing and auditing compliance procedures. Collaborate with project teams to ensure adherence to industry codes and enhance training initiatives, dri...
2 weeks ago
Senior Procurement Compliance Specialist
$110K - $130K *
Unlock potential by serving as a subject matter expert in procurement compliance, guiding complex regulatory matters, and enhancing audit readiness. Collaborate with stakeholders to ensure consistent...
3 days ago
Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA
$110K - $125K *
Join a team that's dedicated to enhancing contamination control and sterility assurance across multiple manufacturing sites. Lead strategic initiatives to ensure compliance, operational excellence, an...
2 weeks ago
Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA
$110K - $125K *
Champion contamination control and sterility assurance across multiple sites, driving strategic initiatives and compliance to enhance product quality and patient safety while ensuring operational exce...
2 weeks ago
Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA
$110K - $125K *
Join us in leading contamination control and sterility assurance programs across multiple manufacturing sites, ensuring compliance and operational excellence while enhancing product quality and patien...
2 weeks ago
Senior Manager, Contamination Control and Sterility Assurance, RFM, QARA
$110K - $125K *
Empower our contamination control and sterility assurance initiatives across multiple manufacturing sites, ensuring compliance and operational excellence while enhancing product quality and patient sa...
2 weeks ago
Senior Quality Systems Specialist
$110K - $130K *
Drive excellence in quality management systems by ensuring compliance with ISO 13485:2016 and regulatory standards. Collaborate cross-functionally to enhance quality culture, support audits, and lead...
2 weeks ago
Principal Engineer, Digital Regulatory Assurance (Life Sciences)
$130K - $155K *
Lead quality assurance and regulatory compliance efforts in a dynamic life sciences environment. Drive modernization through automation and AI, ensuring adherence to GxP standards while enhancing insp...
3 weeks ago
Senior Corporate Compliance Specialist
$80K - $95K *
Champion compliance excellence by leading privacy initiatives, conducting investigations, and ensuring adherence to regulations. Collaborate with teams to enhance processes and mitigate risks while se...
Yesterday
Senior Scientist, Large Molecule Bioanalytical
$64K - $133K *
Engage in complex large-molecule bioanalytical method development, leading scientific studies and collaborating with clients to deliver innovative solutions that support drug development programs...
Reposted 2 days ago
R&D and Regulatory Systems Lead
$95K - $193K *
Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...
Reposted 1 week ago
$140K - $160K *
Elevate quality assurance standards by leading a skilled team to develop, implement, and maintain robust quality management systems for critical IT solutions, ensuring compliance and operational excel...
2 weeks ago
Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy
$222K - $303K *
Join us to lead global regulatory strategy for innovative development programs, ensuring alignment with business objectives and efficient lifecycle management across major markets while influencing ke...
Reposted today
Associate Director, Regulatory Operations
$167K - $207K *
Lead the charge in shaping regulatory operations by enhancing submission processes, governance, and systems. Drive high-quality global submissions while fostering collaboration and visibility across t...
2 weeks ago
Regulatory Data Excellence & Integrity Lead
$124K - $207K *
Drive data excellence by overseeing global regulatory data management activities, ensuring integrity and quality across multiple regions and products. Collaborate with cross-functional teams to innova...
4 days ago
Regulatory Data Excellence & Integrity Lead
$124K - $207K *
Unlock potential by overseeing global data management activities, ensuring data integrity and quality across regulatory systems. Drive innovation and efficiency through strategic initiatives, while co...
4 days ago
Senior Legal Contract Manager (US)
$78K - $156K *
Join a dynamic team as you manage complex commercial contracts, balancing legal and business needs. Collaborate with cross-functional stakeholders to drive negotiations and enhance contracting process...
Reposted 2 days ago
Sr. Clinical Research Associate, Biospecimen Management
$135K - $145K *
Elevate your career by managing laboratory and biospecimen operations for clinical studies. Oversee vendor performance, ensure compliance, and mentor team members while driving project success across...
2 weeks ago
Senior Quality Specialist - Product Release
$88K - $121K *
Optimize the release management of finished goods, ensuring compliance with food safety and regulatory standards while leading a team to address non-conformance and enhance quality assurance processes...
1 week ago
$117K - $184K *
Join a dynamic team to lead vaccine technology transfers, ensuring compliance and efficiency. Drive cross-functional projects, mentor new talent, and enhance process robustness in a fast-paced biophar...
1 week ago
$120K - $145K *
Manage a regulatory team to ensure compliance with FDA and Health Canada standards. Drive regulatory strategy for product innovation and oversee compliance assessments, while collaborating with cross...
3 weeks ago
Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)
$110K - $130K *
Empower product compliance and approvals by overseeing regulatory submissions, collaborating with teams, and delivering insights on regulations for medical devices through their lifecycle. Your expert...
1 month ago
Manager, Quality Systems & Compliance - Deviation/CAPA/Complaints
$110K - $130K *
Lead impactful quality systems and compliance initiatives, overseeing deviation, CAPA, and complaints management. Collaborate across functions to enhance quality performance and drive continuous impro...
Reposted today
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.