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.
$117K - $184K *
Join a dynamic team to lead vaccine technology transfers, ensuring compliance and efficiency. Drive cross-functional projects, mentor new talent, and enhance process robustness in a fast-paced biophar...
1 week ago
$120K - $145K *
Manage a regulatory team to ensure compliance with FDA and Health Canada standards. Drive regulatory strategy for product innovation and oversee compliance assessments, while collaborating with cross...
3 weeks ago
Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)
$110K - $130K *
Empower product compliance and approvals by overseeing regulatory submissions, collaborating with teams, and delivering insights on regulations for medical devices through their lifecycle. Your expert...
4 weeks ago
Manager, Quality Systems & Compliance - Deviation/CAPA/Complaints
$110K - $130K *
Lead impactful quality systems and compliance initiatives, overseeing deviation, CAPA, and complaints management. Collaborate across functions to enhance quality performance and drive continuous impro...
Yesterday
Alltrista - Director, Quality Systems & Regulatory Affairs
$120K - $150K *
Shape quality excellence and compliance by leading regulatory strategies, fostering team growth, and ensuring robust quality management systems in alignment with industry standards and corporate goals...
Reposted 1 week ago
Associate Director, CMC Regulatory Affairs
$181K - $224K *
Elevate global CMC regulatory strategies for commercial compounds. Collaborate cross-functionally to ensure compliance and timely submissions, while leading projects and maintaining expertise in regul...
2 weeks ago
Associate Director, CMC Regulatory Affairs
$181K - $224K *
Lead the charge in developing global CMC regulatory strategies for commercial compounds, ensuring compliance and timely submissions across multiple regions while collaborating with cross-functional te...
2 weeks ago
Principal Specialist - Quality Validation
$110K - $130K *
Champion the integrity of IT Validation & Compliance within a CDMO, ensuring adherence to cGMPs and regulatory standards by overseeing enterprise software validation and reviewing critical quality del...
4 weeks ago
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
$120K - $145K *
Drive regulatory strategy for US and Canada, ensuring compliance and effective communication with health authorities. Collaborate cross-functionally to support product commercialization and navigate c...
3 weeks ago
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
$130K - $155K *
Lead the development and execution of regulatory strategies for US and Canada, ensuring compliance and effective communication with health authorities. Collaborate cross-functionally to support produc...
3 weeks ago
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
$120K - $145K *
Elevate your career by leading regulatory strategies for US and Canada markets. Drive compliance and innovation for on-market and developing products while collaborating with cross-functional teams to...
3 weeks ago
Manufacturing Compliance Specialist I
$80K - $90K *
Unlock potential by ensuring compliant cell therapy manufacturing through effective deviation investigations, CAPA implementation, and continuous improvement initiatives while collaborating with Quali...
6 days ago
Senior Sustaining Quality Engineer (Post Market)
$97K - $130K *
Join a dynamic team as you empower our medical devices to achieve compliance and excellence post-commercialization, driving quality, safety, and performance improvements through rigorous data analysis...
1 month ago
$146K - $182K *
Transform regulatory strategies in FDA Pharma and IVDR, ensuring compliance and driving product approvals. Collaborate with cross-functional teams, mentor associates, and enhance processes to support...
Reposted 2 weeks ago
Senior Clinical Research Associate
$85K - $100K *
Elevate clinical research effectiveness by leading monitoring visits, ensuring the highest quality standards across diverse therapeutic areas, and facilitating communication between sites and internal...
3 weeks ago
Senior Clinical Research Associate
$95K - $115K *
Advance your career by leading clinical research projects and ensuring compliance with timelines and standards. Collaborate with stakeholders and clinical sites to safeguard subjects' rights and data...
3 weeks ago
Senior Regulatory Affairs Specialist (Wound Closure & Healing) - MedTech Surgery
$92K - $148K *
Elevate patient care by developing global regulatory strategies for innovative medical devices. Collaborate with cross-functional teams to ensure compliance and support product lifecycle management in...
6 days ago
Senior Advisor, Regulatory Starting Material
$153K - $268K *
Champion the regulatory strategy for starting materials in drug manufacturing, ensuring compliance with ICH Q11 and regional guidelines. Collaborate cross-functionally to support late-stage clinical a...
Yesterday
Senior Associate, NA Regulatory FIO
$78K - $108K *
Empower your career by driving regulatory compliance and documentation excellence in product development. Collaborate across teams to ensure high-quality formulation management for OTC drugs, dietary...
2 weeks ago
$110K - $130K *
Champion regulatory strategies and stakeholder relationships to enhance business objectives. Collaborate across teams to navigate complex regulatory landscapes, ensuring compliance and effective commu...
1 week ago
Principal Quality Assurance Specialist, External Manufacturing
$150K - $190K *
Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...
Reposted 3 days ago
Senior Scientist, Quality Control
$95K - $115K *
Unlock the potential of quality control by conducting critical testing and validation. Collaborate with a dynamic team to ensure compliance with regulatory standards while driving continuous improveme...
1 week ago
Spécialiste de la conformité réglementaire
$80K - $95K *
Join a team that's dedicated to ensuring regulatory compliance in a complex pharmaceutical manufacturing environment. Collaborate globally to support quality assurance and maintain adherence to health...
Yesterday
Global Regulatory Affairs Scholar (1 of 2)
$92K - $148K *
Advance your career in regulatory affairs through a dynamic fellowship program. Collaborate with experts, tackle real-world projects, and gain invaluable insights into drug development while enhancing...
Today
Global Regulatory Affairs Scholar (1 of 2)
$92K - $148K *
Empower your career in regulatory affairs through a dynamic fellowship, gaining hands-on experience across diverse therapeutic areas while collaborating with industry leaders to influence drug develop...
Today
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.