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 Director, Contract Compliance & Administration
$205K - $256K *
Partner with us to lead strategic contract compliance and administration, driving operational excellence and revenue optimization across diverse functions. Champion AI and automation initiatives to en...
3 weeks ago
Senior Supplier Quality Engineer
$146K - $194K *
Collaborate with design teams and suppliers to enhance quality processes, ensuring reliable hardware assemblies. Drive supplier engagement and quality readiness throughout product development, leverag...
2 weeks ago
Senior Supplier Quality Engineer
$146K - $194K *
Drive supplier quality processes to ensure high reliability and performance of components for advanced surveillance systems. Collaborate cross-functionally to enhance product quality and supplier perf...
2 weeks ago
Senior Technical Expert & Certification Specialist
$120K - $140K *
Champion compliance and innovation in avionics systems, ensuring adherence to airworthiness standards while driving upgrades and new product development in a collaborative environment...
2 weeks ago
$110K - $130K *
Elevate your career by leading automation design and implementation in manufacturing. Collaborate with cross-functional teams to enhance operational excellence and drive strategic initiatives, ensurin...
Yesterday
Senior Instrumentation Engineer
$100K - $120K *
Deliver instrumentation and controls engineering services, ensuring compliance with specifications, budgets, and timelines. Guide projects, support teams, and drive technical excellence to meet client...
3 weeks ago
Sr. Manager Quality Systems Compliance
$149K - $239K *
Join us in driving compliance excellence by managing quality systems and regulatory processes. You'll lead initiatives, assess risks, and promote continuous improvement across global teams to ensure o...
2 weeks ago
Director, Global Trade Compliance
$190K - $220K *
Drive your career by leading a global trade compliance program, ensuring adherence to international regulations while enhancing governance and operational efficiency across a complex business landscap...
3 weeks ago
Scientist – Process Development, Downstream
$95K - $115K *
Shape the future of biologics manufacturing by leading process development and optimization for downstream purification. Drive technology transfer and scale-up initiatives while collaborating across t...
Reposted 1 week ago
Senior Sourcing and Procurement Specialist
$104K - $128K *
Join a dynamic finance team to develop strategic sourcing and category management strategies, ensuring effective procurement and supplier performance while fostering collaboration across departments i...
1 week ago
Senior Drug Discovery Scientist
$150K - $180K *
Lead the charge in advancing drug discovery by developing predictive tools and systems. Collaborate with top pharma and AI researchers to enhance decision-making processes and optimize workflows for i...
Today
Senior Manufacturing Engineer 3 - Manuf Eng Specialist
$95K - $115K *
Lead innovative manufacturing projects in a dynamic environment, driving quality and efficiency. Collaborate cross-functionally to enhance processes and implement improvements, ensuring successful har...
1 week ago
Quality Compliance Senior Manager
$132K - $178K *
Lead a dynamic team to optimize quality oversight through data-driven insights, ensuring compliance and continuous improvement in R&D processes. Drive governance and operational excellence in quality...
4 days ago
Bioassay Scientist - Sr. Scientist
$88K - $105K *
Join a dynamic team as a Sr. Scientist, specializing in method establishment and validation for Drug Substances and Products. Leverage your expertise in cGMP laboratories to drive innovative testing s...
3 days ago
Executive Director, Regulatory Affairs
$282K - $344K *
Elevate global regulatory strategies for product development, ensuring compliance and driving innovation. Collaborate with cross-functional teams to navigate complex regulatory landscapes and lead hig...
1 week ago
Executive Director, Regulatory Affairs
$282K - $344K *
Lead the charge in developing global regulatory strategies that drive product development and compliance. Collaborate with cross-functional teams to ensure alignment with clinical and commercial objec...
1 week ago
Executive Director, Regulatory Affairs
$282K - $344K *
Advance global regulatory strategies for product development, ensuring compliance and driving innovation. Collaborate with cross-functional teams to align regulatory planning with clinical and commerc...
1 week ago
Senior Talent Acquisition & Employee Relations Specialist
$90K - $120K *
Lead the charge in talent acquisition and employee relations, shaping a positive workplace culture. Collaborate with HR to attract top talent and enhance employee engagement, making a meaningful impac...
2 weeks ago
Research Specialist/Scientist, PK Bioanalytical Assays
$95K - $115K *
Unlock potential by driving innovative immunology research through hands-on development and execution of bioanalytical assays. Collaborate with cross-functional teams to advance nucleic acid therapeut...
4 weeks ago
Senior Engineer, Cleaning Validation
$108K - $130K *
Lead the charge in commissioning and qualification of equipment and systems, ensuring compliance with global standards and regulatory requirements while guiding junior engineers and collaborating with...
1 week ago
$131K - $237K *
Lead the charge in designing and analyzing mechanical systems for Unmanned Underwater Vehicles (UUVs). Collaborate across disciplines, mentor junior engineers, and ensure innovative solutions meet cus...
Yesterday
Senior Mechanical Designer 2 (Plant 3D / Revit Projects) - Nuclear
$85K - $130K *
Elevate your career by leading mechanical design projects, collaborating with multi-disciplined teams to create innovative 3D models and layouts. Drive efficiency and quality in mechanical deliverable...
3 weeks ago
Lead Electrical Quality Assurance/Quality Control Specialist 2 - Construction Management
$134K - $205K *
Play a key role in ensuring quality standards for heavy industrial construction projects. Collaborate with contractors to oversee compliance, conduct audits, and maintain documentation, ensuring peak...
1 week ago
Sr Principal Supply Chain Planning Specialist
$117K - $176K *
Pioneer supply chain excellence by leading material strategy and procurement efforts. Collaborate with cross-functional teams to ensure timely delivery and optimal resource allocation, driving mission...
2 days ago
Sr Principal Supply Chain Planning Specialist
$112K - $168K *
Join a dynamic team as a Principal Supply Chain Program Planner, overseeing material budgets and supplier management. Drive supply chain activities from development to production, ensuring alignment w...
Reposted 1 week 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.