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.
Associate Director, Regulatory Affairs (Regulatory Intelligence)
$130K - $160K *
Lead regulatory intelligence efforts to ensure compliance and strategic insight within the pharmaceutical landscape. Collaborate across teams to monitor global regulatory changes and support the devel...
3 weeks ago
Senior Director, Regulatory Affairs
$211K - $281K *
Champion regulatory excellence by leading U.S. FDA engagement and strategy for product development, ensuring timely approvals and compliance while driving cross-functional collaboration and organizati...
3 weeks ago
Senior Director, Regulatory Affairs
$222K - $303K *
Optimize regulatory strategies for product development and submissions. Lead cross-functional teams, manage FDA communications, and ensure compliance with global regulations. Drive innovation in regul...
Today
Country Regulatory Specialist (NAMER Submission Expertise) - Hybrid
$67K - $115K *
Empower project success by delivering expert regulatory submissions and compliance. Collaborate with cross-functional teams to ensure adherence to country-specific regulations, timelines, and quality...
1 week ago
Regulatory and Product Steward Specialist
$75K - $101K *
Advance regulatory compliance and product stewardship for diverse filtration and life sciences products, ensuring safety and sustainability while supporting innovation and business growth across globa...
Today
Regulatory and Product Steward Specialist
$75K - $101K *
Champion regulatory compliance and product stewardship for diverse filtration and life sciences products, ensuring safety and sustainability while driving business growth and innovation across global...
Yesterday
Manager, Regulatory Operations - Regulatory Data Management (Devices)
$119K - $154K *
Lead the charge in regulatory operations, ensuring compliance and quality for medical devices. Oversee documentation systems, manage global submissions, and guide teams to achieve project goals while...
3 weeks ago
Manager Regulatory Affairs Advertising and Promotion
$122K - $176K *
Lead regulatory strategies for advertising and promotion in the pharmaceutical sector. Collaborate with cross-functional teams to address complex issues, ensuring compliance and maximizing product imp...
2 days ago
Manager Regulatory Affairs Advertising and Promotion
$122K - $176K *
Drive regulatory strategies for advertising and promotion, collaborating with cross-functional teams to ensure compliance and maximize product impact. Oversee projects with minimal supervision while p...
2 days ago
Manager, Regulatory Operations - Regulatory Data Management (Devices)
$119K - $154K *
Transform regulatory operations by leading teams to ensure compliance and quality in medical device submissions. Oversee projects, manage documentation systems, and drive continuous improvement to mee...
3 weeks ago
Senior Manager, Regulatory Affairs
$145K - $175K *
Champion regulatory strategy for innovative digital health products, leading a team to ensure compliance and market readiness. Collaborate across functions to navigate complex regulations and drive su...
5 days ago
Regulatory Affairs Strategist, Globalization (eIFU/ Est. Registrations)
$137K - $220K *
Elevate your career by driving global regulatory strategies and practices. Collaborate with cross-functional teams to ensure compliance and efficiency in labeling and registration processes, while lev...
Yesterday
Senior Manager, Regulatory Affairs
$125K - $150K *
Join a dynamic team and take ownership of regulatory activities for various pharmaceutical products, providing guidance and ensuring compliance while collaborating with cross-functional teams across N...
Reposted 3 weeks ago
Export Compliance Specialist - Regulatory & Contracts
$104K - $130K *
Help us ensure compliance with export regulations while collaborating across teams to implement effective processes. This role is vital in supporting trade compliance and managing risk in a dynamic ae...
Today
Associate Director, Regulatory Affairs, CMC- Biologics
$170K - $231K *
Transform your career by leading global CMC regulatory strategies for innovative therapeutics. Collaborate across teams to navigate complex regulatory landscapes and drive the development of cutting-e...
2 weeks ago
Associate Director, Regulatory Affairs, CMC- Biologics
$170K - $231K *
Strategize global CMC regulatory approaches for innovative therapeutics, bridging research and development. Lead regulatory submissions and guide teams through evolving landscapes, ensuring compliance...
2 weeks ago
$78K - $110K *
Empower your career by providing advanced paralegal services in regulatory compliance. Collaborate with attorneys and clients on complex legal matters, ensuring timely filings and maintaining essentia...
3 weeks ago
$78K - $110K *
Drive impactful paralegal services for regulatory compliance and legal matters. Collaborate with attorneys and clients to ensure timely filings, maintain records, and support complex projects while me...
3 weeks ago
Regulatory Affairs Manager (Atlanta)
$100K - $120K *
Empower medical device compliance by reviewing and submitting regulatory documentation. Collaborate across teams to secure timely approvals while ensuring adherence to FDA, ISO 13485, and global stand...
4 weeks ago
INGENYX - Regulatory Affairs Specialist
$87K - $131K *
Optimize global regulatory activities for medical devices, ensuring compliance in labeling, UDI, and product data. Collaborate with cross-functional teams to support product registrations and maintain...
1 week ago
Project Manager, New Product Development (Regulatory Affairs)
$95K - $133K *
Lead the New Product Development (NPD) submission process, ensuring strategic alignment and risk mitigation. Collaborate with internal teams and partners to optimize regulatory submissions and respons...
3 weeks ago
Project Manager, New Product Development (Regulatory Affairs)
$95K - $133K *
Accelerate progress at the forefront of New Product Development by leading regulatory submissions, ensuring compliance, and collaborating with internal and external teams to drive successful product l...
3 weeks ago
International Regulatory Affairs Specialist - APAC
$80K - $100K *
Join a team that's dedicated to advancing global market access for medical devices. Leverage your regulatory expertise to support product registrations and ensure compliance while collaborating with c...
1 week ago
Senior Manager, Regulatory Program Support (RPS)
$140K - $170K *
Manage regulatory program support by coordinating submissions, ensuring compliance, and driving operational excellence across cross-functional teams. Collaborate with global leads to deliver high-qual...
1 week ago
Senior Manager, Regulatory Sciences Compliance
$135K - $183K *
Drive compliance excellence by leading the development and oversight of regulatory frameworks across diverse functions, ensuring alignment with global standards and fostering continuous improvement th...
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.