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 Field Applications Specialist - East Coast
$83K - $95K *
Engage with customers to validate and support Chemistry and Immunoassay instruments, ensuring compliance with specifications and regulatory standards while providing training and operational assistanc...
1 week ago
QA Specialist II-Raw Materials Compliance
$80K - $95K *
Join a dynamic team as you ensure the quality and compliance of raw materials, collaborating across functions to support life-changing therapies while driving continuous improvement and maintaining in...
1 week ago
Senior Sales Specialist – Government Risk State Business
$199K - $370K *
Optimize your sales expertise by driving revenue in state government sectors. Leverage your knowledge of procurement processes to build relationships and close deals, while collaborating with a top-ti...
2 weeks ago
Regulatory Affairs & Compliance (Medicine/Pharma)
$90K - $110K *
Manage market authorization strategies for medicinal products, ensuring compliance and regulatory integrity within the Canadian pharmaceutical landscape through effective submissions and agency intera...
Reposted 4 weeks ago
Senior Director, Regulatory Affairs-CA
$210K - $240K *
Lead the charge in shaping regulatory strategy for innovative medical devices. As the key regulatory authority, oversee submissions, compliance, and cross-functional collaboration to drive the success...
Reposted yesterday
Associate Director, Compliance Field Commercialization, Lung
$177K - $221K *
Empower compliance excellence by leading the NSCLC field compliance program. Collaborate with cross-functional teams to identify risks, develop scalable solutions, and ensure adherence to regulations...
1 week ago
$111K - $166K *
Join a dynamic team as you lead validation activities in aseptic manufacturing, focusing on cleaning validation. Utilize your expertise to ensure product quality and regulatory compliance while collab...
1 week ago
Project Specialist I, Manufacturing
$90K - $120K *
Champion efficient manufacturing operations by managing technical documentation, scheduling, and training. Drive continuous improvement and cross-functional collaboration to ensure production readines...
3 weeks ago
Quality Engineering Specialist
$77K - $98K *
Lead quality initiatives by implementing robust QA practices, ensuring compliance with AS9100 and ISO9001, conducting audits, and collaborating with engineering teams to achieve product excellence and...
3 weeks ago
Senior Environmental Compliance Specialist - Westminster, CO
$100K - $125K *
Champion environmental stewardship by ensuring compliance with regulations, conducting assessments, and delivering strategic guidance to protect human health and the ecosystem during long-term mainten...
Reposted 3 days ago
Senior Requirements Engineer- MBSE
$135K - $216K *
Transform your career by collaborating with cross-functional teams to define and document mission planning specifications, ensuring clarity and traceability in a complex systems environment. Drive inn...
3 days ago
Senior Director, Quality Systems and Compliance
$230K - $270K *
Lead the charge in defining and executing the global compliance strategy for clinical development, fostering a quality-centric culture while ensuring adherence to regulatory standards and continuous i...
Reposted 3 weeks ago
Associate II, Quality Control, Stability
$63K - $100K *
Advance your career by supporting GMP stability programs, ensuring compliance and efficiency in QC operations. Collaborate with a dedicated team to maintain high standards in laboratory practices and...
1 week ago
Job Posting Title Scientist I - Regulatory Affairs
$68K - $94K *
Optimize regulatory compliance for food ingredients by evaluating, advising, and ensuring adherence to US and Canadian regulations. Collaborate with cross-functional teams to address labeling, safety...
1 week ago
Post Market Surveillance Specialist, Contract
$80K - $95K *
Analyze post-production data and lead compliance initiatives to ensure regulatory adherence. Collaborate with cross-functional teams to compile reports, conduct meetings, and mentor personnel, while c...
3 weeks ago
Supervisor, External Quality Assurance
$100K - $120K *
Optimize quality assurance processes by leading a team in a dynamic CDMO environment. Ensure compliance with regulatory standards while driving continuous improvement and effective communication acros...
2 weeks ago
Senior Specialist, End-to-end Planner
$106K - $167K *
Join a team that's redefining supply chain management for Vaccines. This role oversees demand and inventory planning, ensuring optimal product availability while collaborating across functions to enha...
2 days ago
Director, Regulatory Operations
$147K *
Lead the charge in managing a dynamic production team to optimize resources, enhance operational efficiency, and ensure compliance across campaigns while delivering exceptional results aligned with st...
Today
Director, Regulatory Operations
$147K *
Lead a dynamic team to optimize production operations, ensuring compliance and efficiency across campaigns. Collaborate with clients and partners to enhance quality and deliver results aligned with st...
1 week ago
Senior Director, GxP Quality Assurance
$160K - $200K *
Deliver comprehensive quality management solutions across GLP, GCP, and GMP domains, ensuring audit readiness, vendor compliance, and regulatory adherence, while fostering collaboration between R&D, C...
4 weeks ago
Senior Manager, Regulatory Affairs (Energy Markets & Transmission)
$150K - $175K *
Elevate your career by leading regulatory strategy in energy markets. Drive policy development, engage stakeholders, and influence outcomes to support data center growth and energy supply initiatives...
2 weeks ago
Senior Manager, Regulatory Affairs (Energy Markets & Transmission)
$150K - $175K *
Transform regulatory strategies in energy markets by leading engagement with key stakeholders, influencing policy outcomes, and aligning business objectives with market developments to drive growth an...
2 weeks ago
$105K - $115K *
Join a team that's dedicated to ensuring billing compliance and accuracy. In this senior role, you'll manage client guidelines, oversee billing processes, and collaborate cross-functionally to enhance...
1 week ago
Preclinical Research Associate Director
$137K - $235K *
Join a dynamic team to drive preclinical evidence strategies and foster physician collaborations, enhancing innovative medical solutions that improve patient outcomes through strategic partnerships an...
2 days ago
Senior Talent Acquisition Specialist
$90K - $110K *
Shape the future of talent acquisition by managing full-cycle recruiting for infrastructure roles. Collaborate with leaders to enhance hiring strategies, improve candidate experiences, and drive recru...
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.