Remote Regulatory Compliance Specialist – Vaccines (contract) jobs in United States
cer-icon
Apply on Employer Site
company-logo

Sanofi · 6 hours ago

Remote Regulatory Compliance Specialist – Vaccines (contract)

positionUnited States
timeContract
remoteRemote
seniorityMid, Senior Level
date2+ years exp

Sanofi is seeking a Remote Regulatory Compliance Specialist to support the Vaccines Regulatory Science & Operations team. This role is responsible for ensuring regulatory compliance across product licenses, change controls, and CMC documentation for site registrations in key markets.

Health CareLife SciencePharmaceuticalTherapeutics
check
H1B Sponsor Likelynote

Responsibilities

Manage change controls, product license commitments, submissions, and approvals in key markets
Ensure ongoing regulatory compliance for license registrations and batch release activities
Review and approve site documents, including Standard Operating Procedures (SOPs), Site Master Files, and Product License Commitments
Author and maintain CMC regulatory documents (Modules 2 and 3) to support Marketing Authorizations, Annual Reports, and site registrations
Prepare responses to Health Authority questions related to CMC with input from site experts
Represent RSO on M&S and MSAT project teams when regulatory expertise is required

Qualification

Regulatory complianceGMP knowledgeCMC documentationGlobal regulationsMS Office proficiencyPrioritization skillsVeeva Vault experienceHealth Authority interactionCommunication skillsIndependent work

Required

Bachelor's or Master's degree in a related field
2–6 years of experience in the pharmaceutical/biopharmaceutical industry, regulatory compliance, or related manufacturing environment
Strong knowledge of GMP and CMC documentation (Modules 2 and 3)
Understanding of global regulations, Health Authority/Industry guidelines, and regulatory trends
Ability to work independently, manage multiple priorities, and communicate effectively with internal stakeholders
Proficiency in MS Office (Word, Excel, PowerPoint)

Preferred

Experience with Veeva Vault
Previous Sanofi regulatory experience
International regulatory experience
Experience working directly with Health Authorities or creating responses to Health Authority inquiries

Company

Sanofi

twittertwittertwitter
Glassdoor4.0
company-logo
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
dateFounded in 1973
location
Paris, Ile-de-France, FRA
people-size10001+ employees
web-link
https://www.sanofi.com

H1B Sponsorship

Sanofi has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)

Funding

Current Stage
Public Company
Total Funding
$6.97B
Key Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B

Leadership Team

leader-logo
Paul Hudson
Chief Executive Officer
linkedin
leader-logo
Francois-Xavier Roger
Chief Financial Officer
linkedin

Recent News

FierceBiotech
Sanofi plans global filings for key eczema prospect despite mixed phase 3 readout
2026-01-25
BioWorld Financial Watch
Undeterred by mixed data, Sanofi plans amlitelimab filings
2026-01-25
Morningstar.com
Health Care Down as Traders Hedge on Earnings Prospects - Health Care Roundup
2026-01-24
Company data provided by crunchbase