Join Sanofi as a GRA CMC Lead for Vaccines, where you'll drive regulatory strategies for vaccine development, ensuring compliance throughout the product lifecycle. Collaborate with diverse teams to make a significant impact in public health by facilitating timely regulatory submissions and communication with health authorities.
Key Responsibilities
Develop regulatory CMC strategy for assigned project(s)/product(s)
Compile information for regulatory CMC strategy support
Prepare and coordinate CMC documents for regulatory submissions
Manage contacts with regulatory agencies
Provide regulatory guidance to project/product teams
Required Qualifications
Bachelor's degree in a relevant discipline
4+ years of pharmaceutical industry experience
4+ years CMC regulatory experience
Experience with preparation & management of filings
Experience responding to Health Authority comments
Experience working in a matrix environment
Strong organization skills
Concise and persuasive communication skills
Strong Regulatory knowledge
Preferred Qualifications
Master's degree
Foundational understanding of Artificial Intelligence
Strong background in drug development, manufacturing, or testing
Proficient in MS Word, Excel, PowerPoint
Demonstrated ability to work on global project teams
Benefits & Perks
High-quality healthcarePrevention and wellness programs14 weeks’ gender-neutral parental leaveOpportunities for career growth