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.
Quality Engineer 3, Design Assurance
$100K - $150K *
Drive quality assurance initiatives throughout product development, ensuring compliance with industry standards. Collaborate cross-functionally to enhance design processes, manage risks, and support r...
3 days ago
$110K - $130K *
Empower your career by overseeing diverse projects from conception to execution. You'll lead teams, enhance client engagement, and drive growth for successful program management across multiple contra...
Reposted 2 weeks ago
Executive Director, Quality Assurance
$160K - $260K *
Pioneer strategic leadership in Quality Assurance, ensuring compliance and excellence across U.S. operations. Drive continuous improvement and operational excellence while managing a high-performing t...
4 days ago
Senior Supplier Quality Engineer
$85K - $100K *
Lead the charge in enhancing supplier quality across global operations. Drive supplier performance improvements, manage risk, and ensure compliance in the medical device and aerospace sectors while co...
2 weeks ago
$90K - $100K *
Join a team that's passionate about transforming complex scientific data into engaging communications. Collaborate with cross-functional experts to deliver high-quality medical content and strategies...
Reposted 1 week ago
Senior Electrical Systems Engineer
$116K - $194K *
Support our mission by providing technical leadership in electrical systems for naval ship design. Collaborate with multiple teams to assess risks, resolve issues, and ensure compliance with specifica...
1 week ago
Senior Electrical Systems Engineer
$116K - $194K *
Shape the future of electrical systems engineering by leading technical assessments, collaborating with diverse teams, and driving innovative solutions for naval ship modernization efforts in a dynami...
1 week ago
cGMP Computer System Validation Specialist
$95K - $115K *
Join a team that's dedicated to maintaining validated computer systems under cGMP and 21 CFR Part 11. You'll oversee validation processes, ensure compliance, and support audits, all while collaboratin...
3 weeks ago
$145K - $165K *
Join a team that's dedicated to overseeing complex mechanical inspections for a prestigious expansion project, ensuring compliance with safety and engineering standards while managing contractor perfo...
Reposted 2 weeks ago
Senior Specialist, Purchasing/ Procurement
$85K - $102K *
Transform procurement processes by coordinating material acquisition, ensuring timely delivery, and maintaining supplier relationships to meet quality and cost objectives while supporting business ope...
2 weeks ago
$145K - $185K *
Lead the charge in advanced defense and aerospace programs, bridging engineering with business. Collaborate across teams to drive mission success while managing project scope, timelines, and technical...
Reposted 4 weeks ago
$116K - $147K *
Transform IT capabilities by leading systems integration efforts, enhancing existing processes, and supporting project management initiatives. Collaborate with teams to deliver innovative solutions an...
4 days ago
$116K - $147K *
Unlock potential by leading complex IT system integrations and enhancements. Collaborate with teams to modernize capabilities, ensuring operational excellence and effective project management within a...
4 days ago
$85K - $100K *
Empower a high-performing team by driving quality standards and compliance in a fast-paced environment. Oversee data review processes, develop SOPs, and collaborate with stakeholders to ensure operati...
1 week ago
Senior Manager/Associate Director, QA Investigations and Quality Projects
$173K - $226K *
Unlock potential by leading complex quality investigations and CAPA activities. Collaborate with cross-functional teams to ensure compliance, drive process improvements, and deliver timely project out...
2 weeks ago
$92K - $119K *
Champion quality excellence by leading projects and enhancing systems to ensure compliance with industry standards. Collaborate cross-functionally to drive improvements in product and service quality...
3 weeks ago
Associate Director, Clinical Trial Devices
$148K - $195K *
Lead device strategy and oversight in clinical drug development, ensuring integration of device-related activities across the clinical lifecycle. Collaborate with cross-functional teams to drive proac...
3 days ago
Senior Electrical Wiring Designer 1 - Nuclear
$77K - $118K *
Collaborate with multi-disciplined teams to design and upgrade power plant electrical systems, producing detailed wiring diagrams and schematics while ensuring compliance with industry standards and s...
2 weeks ago
Senior Electrical Wiring Designer 1 - Nuclear
$77K - $118K *
Engineer and design electrical systems for power plants, collaborating with multidisciplinary teams to produce detailed wiring diagrams and schematics that enhance efficiency and compliance with safet...
3 weeks ago
Senior Quality Manager - Drug Products
$110K - $130K *
Drive quality assurance excellence by leading comprehensive compliance initiatives, managing diverse teams, and implementing effective corrective actions to enhance operational standards across pharma...
Reposted 2 weeks ago
Senior Acquisition Specialist - Secret Clearance
$110K - $140K *
Join a team that's dedicated to enhancing IT acquisition for the U.S. Army. You'll collaborate with stakeholders to manage software contracts, ensuring timely delivery and compliance within a complex...
Yesterday
Senior Technical Manager - Analytical Development
$146K - $272K *
Empower your career with a leadership role in analytical development, guiding a team in flow cytometry methods for cell therapy. Collaborate cross-functionally to drive innovation and ensure complianc...
1 week ago
Associate Director, Clinical Trial Devices
$148K - $195K *
Champion device strategy by leading end-to-end clinical trial device activities, ensuring alignment across teams and stakeholders while driving proactive decision-making throughout the clinical develo...
3 days ago
Senior Automation Engineer - Regulated Environment
$100K - $120K *
Partner with us to innovate solutions in controls and automation, leading large-scale projects in Pharmaceuticals and Life Sciences. Engage with diverse technologies while enabling our clients to exce...
1 month ago
$105K - $157K *
Join a team that's driving innovative packaging solutions from concept to commercialization. This role offers technical leadership on diverse projects, focusing on sustainability, cost efficiency, and...
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.