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 Regulatory Affairs Manager
$175K - $200K *
Join a dynamic team to manage regulatory submissions for oncology products, ensuring compliance and strategic guidance across cross-functional collaborations. Drive high-quality submissions and contri...
Today
Senior Regulatory Affairs Specialist
$82K - $131K *
Engage in regulatory leadership for complex, federally regulated clinical trials. Oversee study start-up, compliance, and mentoring while ensuring adherence to federal regulations and best practices f...
Reposted today
Senior Regulatory Affairs Specialist - Onsite
$92K - $138K *
Drive regulatory data governance and process excellence across multiple product portfolios. Collaborate with cross-functional teams to enhance data quality, ensure compliance, and support digital tran...
3 days ago
$85K - $100K *
Advance regulatory compliance by managing FDA 510(k) submissions and international documentation. Collaborate with cross-functional teams to ensure product safety and efficacy while maintaining up-to...
1 week ago
Senior Regulatory Affairs Specialist
$109K - $174K *
Transform the future of healthcare by coordinating regulatory submissions and strategies for innovative medical devices, ensuring compliance and supporting product lifecycle management in a dynamic en...
Today
Senior Regulatory Affairs Specialist
$109K - $174K *
Lead the charge in regulatory submissions for medical devices, ensuring compliance with federal and state regulations while collaborating with product development teams to enhance product lifecycle ma...
Today
Senior Regulatory Affairs Specialist
$83K - $103K *
Drive success in regulatory affairs by preparing critical submissions for medical and diagnostic devices. Oversee compliance with U.S. and international regulations while collaborating with cross-func...
Reposted 4 days ago
Senior Regulatory Affairs Specialist
$110K - $130K *
Shape the future of regulatory affairs by driving compliance and strategic planning for global product registrations. Collaborate cross-functionally to enhance processes and ensure successful submissi...
4 weeks ago
Senior Regulatory Affairs Specialist
$100K - $120K *
Lead the charge in ensuring compliance with global regulatory standards, facilitating efficient processes for product registration. Collaborate cross-functionally while managing submissions and develo...
4 weeks ago
Regulatory Affairs Consultant - Regulatory Generalist
$100K - $120K *
Take ownership of regulatory support for pharmaceutical programs, managing IND and NDA submissions, health authority interactions, and lifecycle maintenance. Collaborate with cross-functional teams to...
2 weeks ago
Regulatory Affairs Specialist I
$77K - $98K *
Join a team that's dedicated to securing regulatory approvals for innovative medical technologies, ensuring access to life-saving products worldwide while managing multiple submissions and collaborati...
Reposted today
Principal Regulatory Affairs Specialist
$145K - $175K *
Join a dynamic team as a Principal Regulatory Affairs Specialist, driving regulatory strategy and compliance for medical devices. Lead submissions, manage registrations, and mentor cross-functional te...
1 week ago
Senior Specialist, Regulatory Affairs, Medical Devices
$95K - $115K *
Lead the charge in regulatory strategies for medical devices, guiding global submissions and compliance, while mentoring team members to deliver high-quality regulatory outcomes aligned with best prac...
Reposted 3 days ago
Regulatory Affairs Sr Specialist
$89K - $134K *
Accelerate regulatory excellence by guiding product compliance amid dynamic market demands. Collaborate cross-functionally to influence strategy, ensure adherence to regulations, and facilitate succes...
Reposted 3 weeks ago
Regulatory Affairs Senior Specialist
$108K *
Transform your career by driving regulatory strategies for innovative medical devices. Collaborate with cross-functional teams to ensure compliance and facilitate product approvals while navigating co...
1 week ago
Senior Manager, Regulatory Affairs
$120K - $145K *
Transform regulatory strategies for rare disease and cardio-pulmonary drug-device programs. Collaborate with cross-functional teams to ensure compliance and drive successful submissions globally, supp...
1 week ago
Scientific and Regulatory Affairs Specialist
$86K - $119K *
Join a dynamic team as you ensure regulatory compliance for innovative food brands. Collaborate cross-functionally to navigate North American laws, manage claims, and support product development in a...
Today
Senior Regulatory Scientist - Audit & Compliance
$77K - $115K *
Unlock potential by managing regulatory compliance for biocides, overseeing audits and risk management. Collaborate with stakeholders to ensure adherence to EPA regulations and enhance operational eff...
Reposted 2 weeks ago
Senior/Principal Manufacturing Compliance Specialist
$79K - $169K *
Join a high-performing team to drive compliance and operational readiness in a cutting-edge manufacturing facility. Collaborate across functions to ensure seamless startup and long-term excellence in...
3 days ago
Staff Regulatory Affairs Specialist - Pharma
$117K - $188K *
Elevate your career by managing regulatory activities for combination devices and pharmaceuticals. Leverage your expertise to lead submissions, ensure compliance, and collaborate across teams to drive...
2 weeks ago
Staff Regulatory Affairs Specialist - Pharma
$117K - $188K *
Lead regulatory activities for combination devices and pharmaceuticals, ensuring compliance with FDA and global standards. Collaborate across teams to manage submissions and maintain strong relationsh...
2 weeks ago
Staff Regulatory Affairs Specialist - Pharma
$117K - $188K *
Transform regulatory strategies for combination devices and pharmaceuticals, ensuring compliance with FDA and global standards. Lead complex submissions and collaborate across teams to drive successfu...
2 weeks ago
$160K - $190K *
Lead the charge in global regulatory strategy for a late-stage immunology program, driving FDA interactions, submissions, and cross-functional decisions while shaping regulatory infrastructure in a dy...
Reposted 4 days ago
Senior International Regulatory Affairs Specialist
$110K - $176K *
Unlock potential by leading global regulatory submissions for medical devices. You will drive strategy, manage compliance risks, and collaborate across teams to navigate complex regulatory landscapes...
3 weeks ago
Regulatory Affairs Specialist, Corporate Regulatory
$74K - $104K *
Join a dynamic team to enhance global regulatory compliance and market access for life-saving medical products. Collaborate with cross-functional teams to drive process improvements and navigate compl...
6 days 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.