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.
Sr. Specialist, Clinical Research
$105K - $168K *
Elevate your career by leveraging your expertise in communication and technical writing to support innovative medical device solutions. Collaborate with key opinion leaders and ensure compliance with...
2 days ago
Sr. Specialist, Clinical Research
$105K - $168K *
Explore a dynamic role requiring strong communication and analytical skills. Collaborate with clinical personnel and key opinion leaders while ensuring compliance with medical device regulations and c...
2 days ago
Design Assurance Quality Engineer III
$82K - $156K *
Shape the future of medical device quality assurance by providing critical support in product development, compliance, and operational excellence. Collaborate with cross-functional teams to enhance qu...
1 week ago
$98K - $273K *
Optimize statistical programming processes by leading complex dataset development, ensuring compliance with CDISC standards, and mentoring junior programmers to enhance team performance and deliver hi...
1 week ago
Senior Scientist - Cell Therapy Product Characterization
$112K - $168K *
Contribute to innovative cell therapy product characterization by leading method development, analyzing complex datasets, and collaborating across teams to ensure quality and efficacy from preclinical...
Today
$220K - $260K *
Unlock your potential by overseeing global regulatory submissions and compliance strategies. Lead cross-functional teams to ensure successful outcomes while driving project management excellence in a...
Yesterday
Senior Labor Relations Specialist
$115K - $182K *
Empower project management by providing expert guidance on labor relations, ensuring compliance with policies and laws while fostering positive relationships with union representatives and addressing...
5 days ago
Regulatory Publishing Technical Consultant (Regulatory Systems)
$100K - $120K *
Unlock your potential as a Technical Consultant, providing expert support in regulatory publishing systems and document management. Collaborate with teams and clients to troubleshoot issues, enhance s...
1 week ago
Senior Quality Systems Specialist
$110K - $176K *
Join a dynamic team to enhance and implement Quality Systems, ensuring compliance and continuous improvement across projects. Collaborate with cross-functional teams to drive quality initiatives and d...
3 weeks ago
Regulatory Affairs & Quality Associate
$80K - $95K *
Lead the charge in ensuring compliance with global regulatory and quality standards for medical devices. Collaborate across teams to prepare essential documentation and support regulatory submissions...
Yesterday
$110K - $130K *
Join a dynamic team to lead regulatory strategies, ensuring compliance and driving product registrations. Collaborate with cross-functional teams to support growth initiatives and maintain strong rela...
2 weeks ago
Senior Clinical Research Associate - Phase 1 & Data Readiness
$110K - $130K *
Champion independent clinical monitoring for early-phase studies, ensuring data accuracy and regulatory compliance. Collaborate with cross-functional teams to support critical milestones and enhance p...
Yesterday
Senior Specialist, Global Engineering Solutions (GES)
$117K - $184K *
Lead the execution of capital projects in a dynamic team, focusing on process design and startup for high potency API projects. Collaborate across functions to ensure project success while adhering to...
1 week ago
$80K - $95K *
Transform quality assurance processes as a key leader in audits, ensuring compliance with regulatory standards and driving continuous improvement. Collaborate with teams to identify issues and develop...
1 week ago
Director, Global Regulatory Affairs Strategy Lead
$230K - $250K *
Lead innovative regulatory strategies for global product development, ensuring compliance and effective communication with health authorities. Collaborate cross-functionally to guide submissions and m...
1 week ago
Senior Safety Committee Specialist - DSMB
$95K - $115K *
Join us to lead complex safety projects, collaborate globally, and implement pharmacovigilance practices, ensuring product safety and efficacy while working independently and managing day-to-day CEC/D...
5 days ago
$80K - $95K *
Advance equipment reliability and operational efficiency by leading engineering initiatives, collaborating with production teams, and implementing maintenance programs to minimize downtime and enhance...
3 weeks ago
Compliance Documentation Engineer I/II
$75K - $95K *
Analyze and develop compliance documentation for medical devices, ensuring alignment with regulatory standards. Collaborate with cross-functional teams to support product lifecycle activities and main...
2 days ago
Sr. Specialist, Product Development - RDCA
$110K - $112K *
Collaborate with cross-functional teams to drive product development for in vitro diagnostics, ensuring compliance with quality standards and timely project delivery while managing multiple initiative...
2 weeks ago
Senior Clinical Manufacturing Lead II
$120K - $145K *
Join a team that's dedicated to producing high-quality clinical supplies. Lead manufacturing operations, collaborate on formulation development, and ensure compliance with cGMP standards while driving...
1 week ago
$88K - $132K *
Join our team as a Senior Procurement Specialist, where you'll manage procurement processes, negotiate contracts, and ensure compliance with corporate policies. Collaborate with internal customers to...
Today
Senior Manager, Clinical Quality Assurance
$173K - $204K *
Join a team that's dedicated to enhancing clinical quality through effective GCP oversight and audits, supporting clinical studies and ensuring compliance while mentoring the next generation of QA pro...
Reposted 1 month ago
$90K - $112K *
Take ownership of quality assurance processes, ensuring compliance with industry standards and supplier activities. Collaborate with engineering and vendors to enhance product quality and drive contin...
2 weeks ago
Sr. Manager GRA Audits, Inspections and Compliance - Pipeline
$137K - $215K *
Champion global compliance and audit readiness in Regulatory Affairs. Lead cross-functional collaboration, manage GCP audits, and drive continuous improvement initiatives to enhance processes and ensu...
4 days ago
Senior Clinical Scientist - FSP
$110K - $130K *
Champion the clinical execution of complex studies, leading scientific oversight and medical monitoring while collaborating with cross-functional teams to ensure compliance and deliver impactful resul...
5 days 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.