Occupation
Regulatory Affairs Specialist
A Regulatory Affairs Specialist prepares and manages regulatory submissions and documentation to ensure products comply with FDA and other applicable regulations. Working within pharmaceutical, biotech, or medical device companies, they collaborate cross-functionally with quality, clinical, and manufacturing teams while maintaining meticulous attention to detail in documentation management. This role typically serves as an individual-contributor position supporting a Regulatory Affairs Manager or director.
Duties & responsibilities
- Prepare and submit regulatory documentation to FDA and international health authorities for product approvals
- Manage chemistry, manufacturing, and controls (CMC) compliance and strategy throughout product lifecycle
- Review promotional and advertising materials for regulatory compliance with FDA guidance
- Coordinate with cross-functional teams including quality, clinical, and manufacturing on regulatory requirements
- Maintain controlled regulatory documentation systems and ensure accuracy of submissions
- Track regulatory compliance status and manage timelines for approvals and submissions
- Advise internal teams on applicable regulations for pharmaceuticals, biologics, medical devices, or combination products
What Regulatory Affairs Specialist roles involve, from employers’ own postings.
How much does a Regulatory Affairs Specialist make?
Too few Regulatory Affairs Specialist postings state pay to publish a median yet: 6 of 12 open roles do, and we wait for 25.
Who is hiring for Regulatory Affairs Specialist roles?
12 open Regulatory Affairs Specialist roles from 7 employers; the most at Moderna, Biogen and Beckman Coulter.
From employers’ own postings, as of.
Regulatory Affairs Specialist in the job market
Last checked October 28, 2026
- Open roles
- 12
- Employers
- 7
- Median pay
- —
- Disclose pay
- —
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Open Regulatory Affairs Specialist roles (12)
Regulatory Affairs Specialist
Medtronic
Listed on Medtronic’s careers site · Apply there ↗
Regulatory Affairs Specialist
Beckman Coulter
Irvine, CA
Listed on Beckman Coulter’s careers site · Apply there ↗
Regulatory and Start Up Specialist - Netherlands
IQVIA
This role supports the clinical trial site activation process in the Netherlands, managing regulatory submissions, documentation, and stakeholder coordination to ensure trials launch efficiently and compliantly. It suits experienced clinical research professionals who are comfortable navigating European regulatory frameworks and acting as the liaison between trial sponsors, research sites, and internal teams.
Listed on IQVIA’s careers site · Apply there ↗
Senior Regulatory Affairs Specialist
Oura
Remote - United States · $127,500 – $178,000
This role supports regulatory strategy and operations for Oura's software medical devices, handling submissions, documentation, compliance tracking, and cross-functional coordination throughout the product lifecycle. It suits experienced regulatory professionals with a background in medical devices or digital health who thrive managing complex documentation and approval processes in a growing company.
Listed on Oura’s careers site · Apply there ↗
Associate Director Advertising and Promotion, Global Regulatory Affairs
Biogen
Cambridge, MA · $152,000 – $209,000
This role advises Biogen's internal teams on regulatory compliance for pharmaceutical marketing materials, disease education, and medical communications across U.S. and global markets. It suits someone with regulatory expertise in pharmaceutical advertising who can balance legal requirements with business objectives while managing relationships with FDA oversight bodies.
Listed on Biogen’s careers site · Apply there ↗
Global Regulatory CMC Lead
Moderna
Full-time · $142,500 – $256,500
This role manages regulatory chemistry, manufacturing, and controls (CMC) strategy and submissions for pharmaceutical products at Moderna, guiding cross-functional teams through clinical and commercial approval processes. It suits experienced pharmaceutical scientists and engineers ready to lead regulatory strategy work for biologics in a matrix organization.
Listed on Moderna’s careers site · Apply there ↗
Associate Director, Global Regulatory Sciences - CMC
Bristol Myers Squibb
Full-time · $164,020 – $198,759
This role involves developing and managing regulatory compliance documentation for pharmaceutical and cell therapy products across their lifecycle, from clinical trials through post-approval. It suits experienced regulatory professionals who can independently guide technical teams on complex CMC requirements and interface with health authorities on submissions.
Listed on Bristol Myers Squibb’s careers site · Apply there ↗
Senior Regulatory CMC Drug-Device Combination Product Lead
Biogen
Full-time · Remote, USA · $111,000 – $149,000
This role leads regulatory and CMC (Chemistry, Manufacturing, Controls) strategy for medical devices and combination products at a biotechnology company, working across teams to guide submissions and ensure compliance. It suits experienced regulatory professionals with device industry background who want to advance to a leadership position and directly influence the approval pathway for innovative treatments.
Listed on Biogen’s careers site · Apply there ↗
Associate Director, CMC Regulatory Science, International
Moderna
This role oversees regulatory strategy and CMC submissions for mRNA medicines across global health authorities, requiring deep expertise in biologics regulation and manufacturing quality. It suits experienced pharmaceutical professionals with strong scientific credentials who can navigate complex regulatory pathways and lead cross-functional teams toward approval.
Listed on Moderna’s careers site · Apply there ↗
Associate Director, CMC Regulatory Affairs, International
Moderna
This role leads CMC regulatory strategy and compliance activities for Moderna's global mRNA product portfolio, managing submissions to international health authorities across vaccines, oncology, and rare diseases. It suits experienced regulatory professionals with strong biologics CMC expertise and knowledge of EU and international pharmaceutical regulations.
Listed on Moderna’s careers site · Apply there ↗
Likely next role (6)
Where Regulatory Affairs Specialists commonly go next: Regulatory Affairs Manager.
Regulatory Affairs Manager
Harry's
Full-time · New York, NY · $120,000 – $150,000
This role manages regulatory compliance and product launches for a portfolio of grooming and personal care brands across multiple markets and product categories. It suits an experienced regulatory professional who can navigate complex cosmetic and OTC drug requirements while communicating clearly with non-technical business teams.
Listed on Harry's’s careers site · Apply there ↗
Regulatory Affairs Manager
Medtronic
Listed on Medtronic’s careers site · Apply there ↗
Regulatory Affairs Manager
IQVIA
Listed on IQVIA’s careers site · Apply there ↗
Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP)
Biogen
Full-time · Cambridge, MA · $241,000 – $332,000
Lead regulatory strategy and CMC submissions for Biogen's biologics and advanced therapy pipeline, overseeing a team that manages global approvals and manufacturing compliance. This role suits experienced regulatory leaders with deep biologics expertise who thrive in cross-functional collaboration and can navigate complex health authority interactions.
Listed on Biogen’s careers site · Apply there ↗
Senior Director, Global Regulatory Lead Neuroscience
Bristol Myers Squibb
Full-time · $226,750 – $313,460
A senior regulatory leadership role at a major pharmaceutical company guiding the development and commercialization of neuroscience drugs globally. This position suits experienced regulatory professionals with scientific backgrounds who can navigate complex drug development, interface with health authorities, and lead strategic initiatives across multiple markets.
Listed on Bristol Myers Squibb’s careers site · Apply there ↗
Associate Director, Regulatory Data Management & Intelligence
Moderna
$142,500 – $256,500
This role leads regulatory data strategy and governance at a biotech company, owning Veeva Vault capabilities and driving enterprise data standards across global regulatory operations. It suits experienced regulatory or data professionals ready to balance strategic oversight with hands-on execution on complex technology implementations.
Listed on Moderna’s careers site · Apply there ↗
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Via USAJOBS · Apply there ↗
Document Control Specialist
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Listed on Volkert, Inc.’s careers site · Apply there ↗
Compliance Analyst
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Listed on Ranger Boats’s careers site · Apply there ↗
Senior Travel & Expense Compliance Analyst
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Listed on CesiumAstro’s careers site · Apply there ↗
Director, SOX Infrastructure
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Full-time · San Francisco, CA · $230,000 – $300,000
Lead the design and implementation of financial controls over Anthropic's compute and infrastructure spending as the company scales toward going public. This role suits someone with deep SOX expertise who has built controls in complex, high-volume environments and wants to pioneer control approaches in AI infrastructure where established playbooks don't yet exist.
Listed on Menlo Ventures Portfolio’s careers site · Apply there ↗
Director of Global Trade Compliance
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Listed on Voyager’s careers site · Apply there ↗
Employers hiring Regulatory Affairs Specialists
7 in total, most open roles first.
- Moderna5 roles
- Biogen2 roles
- Beckman Coulter1 role
- Bristol Myers Squibb1 role
- IQVIA1 role
- Medtronic1 role
- OOura1 role