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 Assurance Specialist (Deployable)
$88K - $114K *
Engage in quality assurance by designing and implementing risk-based programs, ensuring contractor compliance, and analyzing data for process improvements in support of U.S. Government acquisitions in...
4 days ago
Quality Assurance Specialist (Deployable)
$78K - $101K *
Contribute to quality assurance by designing and implementing risk-based programs, ensuring contractor compliance, and analyzing data for process improvements in support of U.S. Government acquisition...
4 days ago
Quality Assurance Specialist (Deployable)
$82K - $106K *
Take ownership of quality assurance processes by designing and implementing risk-based surveillance programs. Collaborate with multi-functional teams to ensure contractor compliance and enhance operat...
4 days ago
Quality Assurance Specialist (Deployable)
$85K - $111K *
Shape the future of quality assurance by implementing risk-based programs and ensuring contractor compliance in diverse environments. Collaborate with multi-functional teams to enhance processes and s...
4 days ago
Quality Assurance Specialist (Deployable)
$74K - $97K *
Join a team that's dedicated to enhancing quality assurance in diverse environments. This role involves deploying to austere locations, implementing risk-based programs, and ensuring contractor compli...
4 days ago
Quality Assurance Specialist (Deployable)
$78K - $101K *
Unlock your potential by leading quality assurance initiatives in high-stakes environments. Collaborate with multi-functional teams to enhance contractor compliance and drive process improvements whil...
4 days ago
Quality Assurance Specialist (Deployable)
$76K - $99K *
Engage in quality assurance by designing and implementing risk-based surveillance programs. Collaborate with multi-functional teams to ensure contractor compliance and enhance processes, supporting U...
4 days ago
Quality Assurance Specialist (Deployable)
$82K - $106K *
Partner with us to implement a risk-based quality assurance program, ensuring contractor compliance and enhancing processes in diverse environments. Engage in audits, data analysis, and technical supp...
4 days ago
$95K - $110K *
Manage strategic supplier relationships and optimize procurement processes to ensure seamless material flow for manufacturing. Collaborate cross-functionally to drive cost savings and efficiency in a...
3 weeks ago
$95K *
Unlock potential by joining a dynamic team focused on enhancing healthcare quality through data analysis and compliance. Collaborate with operational leaders to drive improvements and ensure exception...
Yesterday
Senior Systems Engineer - Medical Devices & IVD Instruments
$150K - $185K *
Contribute to the design and integration of complex electromechanical systems in medical devices. Leverage expertise in FDA submissions and cross-functional collaboration to ensure compliance, safety...
3 weeks ago
Senior DoD Medical Product Program Manager - Clinical & Regulatory
$110K - $130K *
Join us to lead product management of medical therapeutics, diagnostics, and clinical protocols. Engage in regulatory coordination with FDA and IRB. Drive IND accountability and support innovative sol...
3 weeks ago
Principal/Sr Principal Engineer Supplier Quality (Cleveland- OH)
$94K - $176K *
Join a team that's dedicated to ensuring supplier quality excellence. This role involves managing supplier evaluations, compliance, and performance while traveling extensively to support quality assur...
6 days ago
$122K - $212K *
Lead the charge in executing trade controls strategy for U.S.-Mexico operations, ensuring compliance with import/export regulations. Collaborate with cross-functional teams to monitor risks and drive...
1 week ago
$122K - $212K *
Unlock compliance excellence by leading trade controls for U.S.-Mexico operations. Collaborate with cross-functional teams to ensure adherence to import/export regulations while driving risk managemen...
1 week ago
$122K - $212K *
Champion compliance and trade controls for U.S.-Mexico operations, leading a team to ensure adherence to regulations while collaborating across functions to mitigate risks and drive strategic initiati...
1 week ago
$122K - $212K *
Drive compliance and trade controls for U.S.-Mexico operations, leading a team to ensure regulatory adherence and risk management. Collaborate cross-functionally to enhance trade strategies and monito...
1 week ago
$122K - $212K *
Champion compliance and trade controls for U.S.-Mexico operations, leading a team to ensure adherence to regulations, manage risks, and drive cross-functional collaboration in the Medical Technology s...
1 week ago
$122K - $212K *
Lead compliance initiatives for U.S.-Mexico trade, driving strategy and collaboration across teams. Guide a team of professionals in navigating complex regulations, ensuring adherence to import/export...
1 week ago
$122K - $212K *
Join a dynamic team to lead trade compliance strategies at the U.S.-Mexico Southern Border, ensuring adherence to regulations while collaborating with cross-functional partners to drive operational ex...
1 week ago
Senior Pharmacovigilance Client Account Manager, Client Services
$95K - $115K *
Join a dynamic team to enhance client relationships and ensure top-notch pharmacovigilance services. Drive client success through effective communication, project management, and strategic collaborati...
4 weeks ago
Associate Director, Safety Analysis Scientist
$137K - $235K *
Take ownership of product safety assessments, leading scientific evaluations to ensure compliance and drive safety strategy. Collaborate with cross-functional teams to influence decisions and support...
Reposted 2 weeks ago
$70K - $96K *
Shape the future of biopharmaceutical validation by executing critical protocols, ensuring compliance, and managing projects. Collaborate with cross-functional teams to enhance product quality and dri...
1 week ago
Associate Director, Safety Analysis Scientist
$137K - $235K *
Transform healthcare as you lead product safety evaluations, guide teams, and influence decisions for innovative treatments. Leverage your expertise to drive impactful safety strategies in a dynamic...
Reposted 2 weeks ago
Associate Director, Safety Analysis Scientist
$137K - $235K *
Drive innovative safety strategies as an Associate Director leading safety evaluations and analyses for drug development. Collaborate cross-functionally to support product safety management and regula...
Reposted 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.