# Regulatory Affairs Specialist

Occupation

Canonical page: https://career.thegoodapps.co/occupations/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.

Top skills: [Attention to Detail](https://career.thegoodapps.co/skills/attention-to-detail), [Cross-functional Collaboration](https://career.thegoodapps.co/skills/cross-functional-collaboration)

## Career ladder

- Often comes from: [Regulatory Affairs Associate](https://career.thegoodapps.co/occupations/regulatory-affairs-associate)
- Often leads to: [Regulatory Affairs Manager](https://career.thegoodapps.co/occupations/regulatory-affairs-manager)

## Similar roles

[Clinical Research Associate](https://career.thegoodapps.co/occupations/clinical-research-associate), [Compliance Analyst](https://career.thegoodapps.co/occupations/compliance-analyst), [Compliance Officer](https://career.thegoodapps.co/occupations/compliance-officer), [Director of Regulatory Affairs](https://career.thegoodapps.co/occupations/director-of-regulatory-affairs), [Document Control Specialist](https://career.thegoodapps.co/occupations/document-control-specialist), [Environmental Compliance Specialist](https://career.thegoodapps.co/occupations/environmental-compliance-specialist), [Quality Control Analyst](https://career.thegoodapps.co/occupations/quality-control-analyst)

## Open Regulatory Affairs Specialist roles (11)

- [Regulatory Affairs Specialist](https://onehealthineers.wd3.myworkdayjobs.com/en-US/SHSJB/job/PEK/Regulatory-Affairs-Specialist_R-30168-1) at [Varian Medical Systems](https://career.thegoodapps.co/organizations/varian-medical-systems) — PEK (listed on Varian Medical Systems's own careers site)
- [Associate Director Advertising and Promotion, Global Regulatory Affairs](https://career.thegoodapps.co/jobs/15a959cc-b8d6-4104-87c2-02f59e16b551/associate-director-advertising-and-promotion-global-regulatory-affairs-at-biogen) at [Biogen](https://career.thegoodapps.co/organizations/biogen) — Cambridge, MA, $152,000 – $209,000
- [Principal Scientist, Regulatory Liaison](https://career.thegoodapps.co/jobs/5102c9f1-e9dc-4517-871f-9d9c70646c94/principal-scientist-regulatory-liaison-at-merck) at [Merck](https://career.thegoodapps.co/organizations/merck) — Full-time, $173,200 – $272,600
- [Associate Director, Global Regulatory, CMC](https://career.thegoodapps.co/jobs/2863ce24-bcd5-4ddb-a926-576759b4b6b0/associate-director-global-regulatory-cmc-at-moderna) at [Moderna](https://career.thegoodapps.co/organizations/moderna) — $142,500 – $256,500
- [Associate Director, Global Regulatory Sciences - CMC](https://career.thegoodapps.co/jobs/d6561c3a-a1ee-4b8e-b62d-aa33152b0316/associate-director-global-regulatory-sciences-cmc-at-bristol-myers-squibb) at [Bristol Myers Squibb](https://career.thegoodapps.co/organizations/bristol-myers-squibb) — Full-time, $164,020 – $198,759
- [Senior Regulatory CMC Drug-Device Combination Product Lead](https://career.thegoodapps.co/jobs/e5e507d5-ddd8-4e8f-807b-6e0a6f604126/senior-regulatory-cmc-drug-device-combination-product-lead-at-biogen) at [Biogen](https://career.thegoodapps.co/organizations/biogen) — Full-time, Remote, USA, $111,000 – $149,000
- [Global Regulatory CMC Lead](https://career.thegoodapps.co/jobs/62f4c69d-03ad-42ef-9155-735c532b60ec/global-regulatory-cmc-lead-at-moderna) at [Moderna](https://career.thegoodapps.co/organizations/moderna) — Full-time, $142,500 – $256,500
- [Associate Director, CMC Regulatory Science, International](https://career.thegoodapps.co/jobs/59404fc2-d11e-44b2-8a4e-115fb86b6b5a/associate-director-cmc-regulatory-science-international-at-moderna) at [Moderna](https://career.thegoodapps.co/organizations/moderna)
- [Associate Director, CMC Regulatory Affairs, International](https://career.thegoodapps.co/jobs/a7655413-34f8-4255-95e5-a7cfadf6aca2/associate-director-cmc-regulatory-affairs-international-at-moderna) at [Moderna](https://career.thegoodapps.co/organizations/moderna)
- [Associate Director, Global Regulatory Science, CMC](https://career.thegoodapps.co/jobs/e8d03bee-d8d4-40c5-a1bb-8d2d33cba85f/associate-director-global-regulatory-science-cmc-at-moderna) at [Moderna](https://career.thegoodapps.co/organizations/moderna)

All 11 open roles: https://career.thegoodapps.co/jobs?q=Regulatory%20Affairs%20Specialist

## Likely next role (14)

Where Regulatory Affairs Specialists commonly go next: [Regulatory Affairs Manager](https://career.thegoodapps.co/occupations/regulatory-affairs-manager).

- [Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP)](https://career.thegoodapps.co/jobs/d8a16cc9-12d3-4aa7-bdf4-94cfdd182d9f/head-of-regulatory-cmc-biologics-advanced-therapy-medicinal-products-atmp-at) at [Biogen](https://career.thegoodapps.co/organizations/biogen) — Full-time, Cambridge, MA, $241,000 – $332,000
- [Senior Manager, Regulatory Operations and Transformation](https://career.thegoodapps.co/jobs/8fa1daeb-f52e-424c-acf2-d07716218447/senior-manager-regulatory-operations-and-transformation-at-medtronic) at [Medtronic](https://career.thegoodapps.co/organizations/medtronic) — Full-time, Lafayette, CO, $154,400 – $231,600
- [Senior Director, Global Regulatory Lead Neuroscience](https://career.thegoodapps.co/jobs/b9b95e1e-f813-4456-b342-c0d0c9bf42ac/senior-director-global-regulatory-lead-neuroscience-at-bristol-myers-squibb) at [Bristol Myers Squibb](https://career.thegoodapps.co/organizations/bristol-myers-squibb) — Full-time, $226,750 – $313,460
- [Associate Director, Regulatory Affairs](https://career.thegoodapps.co/jobs/a8166e67-399e-4304-b8df-f438627824fd/associate-director-regulatory-affairs-at-moderna) at [Moderna](https://career.thegoodapps.co/organizations/moderna) — Full-time, CA$171,000 – CA$189,000
- [Head of CMC Regulatory Affairs – Small Molecules](https://career.thegoodapps.co/jobs/42346a03-4592-421c-8470-134775bf191b/head-of-cmc-regulatory-affairs-small-molecules-at-gilead-sciences) at [Gilead Sciences](https://career.thegoodapps.co/organizations/gilead-sciences) — Full-time, United States - California - Foster City, $302,005 – $390,830
- [Director of Regulatory Affairs and Quality Assurance (RA / QA)](https://career.thegoodapps.co/jobs/4b81a714-4671-41d0-9f22-a783f32b6918/director-of-regulatory-affairs-and-quality-assurance-ra-qa-at-eight-sleep) at [Eight Sleep](https://career.thegoodapps.co/organizations/eight-sleep) — Full-time, San Francisco, CA
- [Associate Director, GRS Heme/Onc](https://career.thegoodapps.co/jobs/32039726-32ea-4f92-84af-fa76abccf70a/associate-director-grs-heme-onc-at-bristol-myers-squibb) at [Bristol Myers Squibb](https://career.thegoodapps.co/organizations/bristol-myers-squibb) — Full-time, Princeton, NJ, $173,350 – $210,058
- [Associate Director, Regulatory Data Management & Intelligence](https://career.thegoodapps.co/jobs/e0e8f7b2-0804-476f-8a71-7c867a7136f9/associate-director-regulatory-data-management-intelligence-at-moderna) at [Moderna](https://career.thegoodapps.co/organizations/moderna) — $142,500 – $256,500
- [Exec Director, Regulatory Affairs](https://career.thegoodapps.co/jobs/1635a641-2e3a-48ed-a624-7037fc647f82/exec-director-regulatory-affairs-at-gilead-sciences) at [Gilead Sciences](https://career.thegoodapps.co/organizations/gilead-sciences) — Full-time, $302,005 – $390,830
- [Associate Director Global Regulatory Sciences - Oncology](https://career.thegoodapps.co/jobs/87c5fd51-cf75-456f-acf0-922d1c40d5ba/associate-director-global-regulatory-sciences-oncology-at-bristol-myers-squibb) at [Bristol Myers Squibb](https://career.thegoodapps.co/organizations/bristol-myers-squibb) — Full-time, $173,350 – $241,566

## Roles similar to Regulatory Affairs Specialist (43)

From [Clinical Research Associate](https://career.thegoodapps.co/occupations/clinical-research-associate), [Compliance Analyst](https://career.thegoodapps.co/occupations/compliance-analyst), [Compliance Officer](https://career.thegoodapps.co/occupations/compliance-officer), [Director of Regulatory Affairs](https://career.thegoodapps.co/occupations/director-of-regulatory-affairs), [Document Control Specialist](https://career.thegoodapps.co/occupations/document-control-specialist), [Environmental Compliance Specialist](https://career.thegoodapps.co/occupations/environmental-compliance-specialist), [Quality Control Analyst](https://career.thegoodapps.co/occupations/quality-control-analyst).

- [Document Control Specialist](https://job-boards.greenhouse.io/voyagertechnologiesinc/jobs/4377958009) at [Voyager](https://career.thegoodapps.co/organizations/voyager) — Penrose, CO (listed on Voyager's own careers site)
- [Compliance Officer](https://usbank.wd1.myworkdayjobs.com/en-US/US_Bank_Careers/job/Milwaukee-WI/Compliance-Officer_2026-0019886) at [U.S. Bank](https://career.thegoodapps.co/organizations/u-s-bank) (listed on U.S. Bank's own careers site)
- [Compliance Analyst](https://oxy.wd5.myworkdayjobs.com/en-US/Corporate/job/The-Woodlands-Texas/Compliance-Analyst_JR108804-1) at [Occidental Petroleum](https://career.thegoodapps.co/organizations/occidental-petroleum) — The Woodlands, Texas (listed on Occidental Petroleum's own careers site)
- [Clinical Research Associate](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Reading-Berkshire-United-Kingdom/Clinical-Research-Associate---Ireland_R1514135) at [IQVIA](https://career.thegoodapps.co/organizations/iqvia) (listed on IQVIA's own careers site)
- [Document Control Specialist](https://flir.wd1.myworkdayjobs.com/en-US/flircareers/job/US---Montgomeryville-PA-TDY/Document-Control-Specialist_REQ28071-1) at [FLIR Systems](https://career.thegoodapps.co/organizations/flir-systems) — Montgomeryville, PA (listed on FLIR Systems's own careers site)
- [Document Control Specialist](https://career.thegoodapps.co/jobs/c246aa2f-1f77-43e5-a475-fde6d6453358/document-control-specialist-at-drivetime) at [DriveTime](https://career.thegoodapps.co/organizations/drivetime) — Mesa, AZ
- [BSA/AML Officer](https://career.thegoodapps.co/jobs/88e895b9-8001-4fb0-b0dd-a2f1162afae4/bsa-aml-officer-at-coindesk) at [CoinDesk](https://career.thegoodapps.co/organizations/coindesk) — Full-time, New York, NY, $175,000 – $215,000
- [Analyst I, Research Grade QC mRNA](https://career.thegoodapps.co/jobs/f77d1830-e4f8-4f96-a4b2-32bf290970de/analyst-i-research-grade-qc-mrna-at-beckman-coulter) at [Beckman Coulter](https://career.thegoodapps.co/organizations/beckman-coulter) — Full-time, Fargo, ND
- [Vice President, Compliance Officer](https://career.thegoodapps.co/jobs/3d430ba6-ab4b-45bc-8bb7-45ab33b0f635/vice-president-compliance-officer-at-cerberus-capital-management) at [Cerberus Capital Management](https://career.thegoodapps.co/organizations/cerberus-capital-management) — New York, NY, $200,000 – $225,000
- [General Compliance Analyst I, II or III](https://career.thegoodapps.co/jobs/62e51c5e-d3fe-4959-8473-e6c8481d5067/general-compliance-analyst-i-ii-or-iii-at-cambia-health-solutions) at [Cambia Health Solutions](https://career.thegoodapps.co/organizations/cambia-health-solutions) — Full-time, $65,000 – $155,000

## People with this title (0)

No one holds this exact title here yet.