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.
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Open Regulatory Affairs Specialist roles (11)
Regulatory Affairs Specialist
Varian Medical Systems
PEK
Listed on Varian Medical Systems’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 ↗
Principal Scientist, Regulatory Liaison
Merck
Full-time · $173,200 – $272,600
This role leads global regulatory strategy for vaccine and infectious disease products, serving as the primary regulatory contact between the company, FDA, and international agencies throughout drug development and commercialization. It suits experienced scientists with strong command of pharmaceutical regulation and the ability to work independently on complex, multi-indication programs.
Listed on Merck’s careers site · Apply there ↗
Associate Director, Global Regulatory, CMC
Moderna
$142,500 – $256,500
This role leads the development and execution of regulatory chemistry, manufacturing, and controls (CMC) strategies for pharmaceutical products throughout their lifecycle, working across global health authority submissions and collaborating with cross-functional teams to bring new medicines to market.
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 ↗
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, 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 ↗
Associate Director, Global Regulatory Science, CMC
Moderna
Lead CMC regulatory strategy development and global submissions for Moderna's mRNA medicine portfolio, working across multiple programs to guide manufacturing and quality teams while representing the company to health authorities. This role suits experienced regulatory professionals with deep biologics expertise who want to shape innovative medicine development at a company-wide scale.
Listed on Moderna’s careers site · Apply there ↗
Likely next role (15)
Where Regulatory Affairs Specialists commonly go next: Regulatory Affairs Manager.
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 Manager, Regulatory Operations and Transformation
Medtronic
Full-time · Lafayette, CO · $154,400 – $231,600
This senior management role oversees regulatory compliance operations, technical communications, and process improvement for a medical device portfolio at a global healthcare company. It suits experienced regulatory affairs leaders who have driven operational excellence and led teams in complex, regulated environments.
Listed on Medtronic’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 Affairs
Moderna
Full-time · CA$171,000 – CA$189,000
An experienced regulatory leader will shape mRNA medicine development strategy for Canada, managing Health Canada submissions and serving as the primary agency liaison while mentoring junior staff and championing innovation in regulatory approaches.
Listed on Moderna’s careers site · Apply there ↗
Head of CMC Regulatory Affairs – Small Molecules
Gilead Sciences
Full-time · United States - California - Foster City · $302,005 – $390,830
This is a senior regulatory leadership role overseeing chemistry, manufacturing, and controls strategy for small-molecule drug programs at a major pharmaceutical company. The position suits someone with deep expertise in CMC regulatory affairs who can drive global approval strategies and lead cross-functional teams through complex product lifecycles.
Listed on Gilead Sciences’s careers site · Apply there ↗
Director of Regulatory Affairs and Quality Assurance (RA / QA)
Eight Sleep
Full-time · San Francisco, CA
Eight Sleep is hiring a Director of Regulatory Affairs and Quality Assurance to lead compliance, risk management, and FDA regulatory strategy for their medical-device sleep technology platform. This role suits experienced medical device professionals ready to shape regulatory practices at a growth-stage company with direct access to leadership and R&D.
Listed on Eight Sleep’s careers site · Apply there ↗
Associate Director, GRS Heme/Onc
Bristol Myers Squibb
Full-time · Princeton, NJ · $173,350 – $210,058
This role leads regulatory strategy and oversees FDA submissions for hematology and oncology drug development at a major pharmaceutical company. It suits experienced regulatory professionals with scientific credentials who can manage complex submissions, lead teams, and coordinate across functions.
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 ↗
Exec Director, Regulatory Affairs
Gilead Sciences
Full-time · $302,005 – $390,830
Lead regulatory strategy for precision medicine diagnostics and companion diagnostics across Gilead's drug portfolio, overseeing both enterprise policy and team execution from early development through global approval. This role suits experienced regulatory professionals with deep expertise in in vitro diagnostics, biomarker development, and health authority interactions who can influence cross-functional teams in a matrix environment.
Listed on Gilead Sciences’s careers site · Apply there ↗
Roles similar to Regulatory Affairs Specialist (43)
From Clinical Research Associate, Compliance Analyst, Compliance Officer, Director of Regulatory Affairs, Document Control Specialist, Environmental Compliance Specialist, Quality Control Analyst.
Document Control Specialist
Voyager
Penrose, CO
Listed on Voyager’s careers site · Apply there ↗
Compliance Officer
U.S. Bank
Listed on U.S. Bank’s careers site · Apply there ↗
Compliance Analyst
Occidental Petroleum
The Woodlands, Texas
Listed on Occidental Petroleum’s careers site · Apply there ↗
Clinical Research Associate
IQVIA
Listed on IQVIA’s careers site · Apply there ↗
Document Control Specialist
FLIR Systems
Montgomeryville, PA
Listed on FLIR Systems’s careers site · Apply there ↗
Document Control Specialist
DriveTime
Mesa, AZ
This role handles vehicle title documents and DMV processing for an auto finance company, managing amendments, corrections, and lien verifications. It suits someone detail-oriented and organized who can thrive in a fast-paced office processing environment with clear procedures and deadlines.
Listed on DriveTime’s careers site · Apply there ↗
BSA/AML Officer
CoinDesk
Full-time · New York, NY · $175,000 – $215,000
Bullish seeks a BSA/AML Officer to establish and lead compliance programs for its regulated US digital asset trading business, overseeing Bank Secrecy Act, anti-money laundering, and sanctions compliance across spot, derivatives, and tokenized securities operations. This role suits compliance professionals with financial crime or regulatory experience who want to shape compliance infrastructure at a major crypto exchange during a period of industry growth.
Listed on CoinDesk’s careers site · Apply there ↗
Analyst I, Research Grade QC mRNA
Beckman Coulter
Full-time · Fargo, ND
This is an entry-level quality control role performing testing and validation work on mRNA products in a research manufacturing environment. The role suits someone with a science degree and basic lab skills who wants hands-on experience in biotech quality assurance.
Listed on Beckman Coulter’s careers site · Apply there ↗
Vice President, Compliance Officer
Cerberus Capital Management
New York, NY · $200,000 – $225,000
This role leads compliance and financial-crime prevention for a major alternative-investment firm's portfolio of private equity, lending, and real-estate businesses. It suits experienced compliance professionals or white-collar litigation attorneys who can manage due diligence, policy development, and monitoring across multiple investment stages and asset classes.
Listed on Cerberus Capital Management’s careers site · Apply there ↗
General Compliance Analyst I, II or III
Cambia Health Solutions
Full-time · $65,000 – $155,000
Compliance Analysts at Cambia design and execute healthcare compliance programs, managing risk assessments, audits, training, and corrective actions across state and federal regulations. The role suits detail-oriented professionals with healthcare compliance experience who can work independently and collaboratively across organizational levels.
Listed on Cambia Health Solutions’s careers site · Apply there ↗
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