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.
Staff Quality Engineer, Internal Audits
$123K - $137K *
Transform quality assurance by leading advanced internal audits to enhance compliance across cardiac assist operations. Drive improvements and coach auditors for regulatory excellence while ensuring r...
3 weeks ago
Oversight Compliance Specialist
$100K - $145K *
Tackle compliance oversight through detailed assessments, reporting, and collaboration with law enforcement partners to ensure program adherence and address deficiencies efficiently across a high-volu...
Reposted 2 weeks ago
Senior Staff Clinical Evaluation Specialist (Remote)
$110K - $183K *
Manage the advancement of clinical evidence strategies to support regulatory submissions and product lifecycle management. Collaborate across functions to optimize clinical evaluations and enhance mar...
Reposted yesterday
Sr. CRA, FSP - Surgical / Medical Device - Central region
$130K - $133K *
Advance clinical research by leading site monitoring and management efforts. Ensure compliance with regulatory standards while overseeing study protocols and data integrity. Collaborate with teams to...
5 days ago
$100K - $115K *
Drive engineering excellence on complex projects, ensuring technical compliance, effective communication, and thorough documentation while supporting project deliverables and managing stakeholder rela...
3 weeks ago
Senior Reliability Engineer, RAPA & TS
$110K - $130K *
Help us enhance electric reliability by leading transmission and resource adequacy studies, collaborating with stakeholders, and applying advanced project management techniques to improve assessment p...
1 week ago
$72K - $104K *
Join a team that's dedicated to ensuring aerospace product quality and compliance. Collaborate across departments to enhance processes, perform inspections, and drive continuous improvement initiative...
2 weeks ago
Manager, Global Regulatory Affairs
$100K - $120K *
Lead the charge in developing global regulatory strategies to ensure compliant product launches. Collaborate with cross-functional teams to navigate complex regulations, manage submissions, and build...
2 weeks ago
Senior Information Collections Specialist
$95K - $115K *
Lead the charge in developing and implementing agency-wide policies for information collection, ensuring compliance with federal regulations while providing expert analysis and guidance to enhance ope...
1 week ago
Senior Corporate Quality Engineer
$95K - $115K *
Elevate your career by leading the development and harmonization of a unified Quality Management System across medical device operations, ensuring compliance and operational excellence through strateg...
3 weeks ago
Senior Packaging Development Engineer I
$81K - $112K *
Join a team that's dedicated to enhancing packaging systems for medical devices. Collaborate across functions to ensure compliance, safety, and efficiency while driving continuous improvement in a fas...
6 days ago
Senior Packaging Development Engineer I
$81K - $112K *
Drive innovative packaging solutions for medical devices by leading projects that ensure compliance, functionality, and sustainability. Collaborate cross-functionally to enhance processes and support...
6 days ago
Senior Packaging Development Engineer I
$81K - $112K *
Transform packaging engineering by leading design and development projects for medical devices. Collaborate cross-functionally to ensure compliance, functionality, and sustainability while driving con...
6 days ago
Senior Packaging Development Engineer I
$81K - $112K *
Drive innovative packaging solutions for medical devices, ensuring compliance and functionality through collaboration and technical expertise. Lead projects from design to validation, enhancing qualit...
6 days ago
$80K - $95K *
Drive quality assurance initiatives in medical devices by leveraging your expertise in ISO standards and regulatory compliance to ensure client products meet international benchmarks for safety and ef...
3 weeks ago
SR DOCUMENT CONTROL SPECIALIST
$80K - $95K *
Join a dynamic team as you oversee document control and vendor data activities on high-profile projects, ensuring quality deliverables and effective communication with clients and project teams to ach...
1 week ago
Senior Clinical Research Associate - Alzheimer's Disease
$95K - $115K *
Manage and oversee clinical monitoring activities, ensuring compliance with protocols and regulations. Collaborate with site personnel and cross-functional teams to support trial execution and maintai...
3 weeks ago
IT Software Validation Specialist
$80K - $95K *
Join a team that's dedicated to ensuring software validation excellence. You'll develop and execute validation documentation, collaborate with users, and maintain compliance with regulatory standards...
Yesterday
Scientist (Analytical Development, Cell Therapy)
$90K - $136K *
Advance the future of cell therapy by developing and delivering innovative analytical methods. Collaborate with cross-functional teams to support product characterization and regulatory filings, ensur...
Today
Quality Record Investigation Lead Consultant
$100K - $120K *
Join a team that's dedicated to reviewing and closing non-conformance records. This role involves project management, client interaction, and ensuring timely delivery while working independently in a...
1 week ago
Associate Director, Quality Assurance - Technical
$150K - $195K *
Empower quality assurance excellence by leading GMP oversight for contract manufacturing and validation projects, ensuring compliance and collaboration across technical operations to support drug deve...
1 week ago
$125K - $150K *
Lead the charge in engineering projects, driving cross-functional collaboration and ensuring manufacturing readiness, process stability, and documentation control in an ISO-regulated environment...
1 month ago
Associate Director, Clinical Quality Assurance
$192K - $226K *
Lead the charge in Clinical Quality Assurance, ensuring compliance and oversight across clinical studies. Drive team growth, develop audit plans, and support continuous improvement while mentoring jun...
Reposted 4 weeks ago
Digital Health Regulatory Affairs Manager
$117K - $201K *
Transform the future of cardiovascular care as you oversee regulatory strategies and submissions for innovative digital health medical devices. Collaborate with global teams to ensure compliance and f...
Reposted 2 weeks ago
Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have)
$114K - $210K *
Join a team that's dedicated to developing high-quality regulatory documents for global submissions. Lead cross-functional projects, mentor junior writers, and ensure compliance with industry standard...
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.