Join Sanofi as a GRA CMC Lead in Vaccines and play a critical role in developing regulatory strategies to bring innovative vaccines to market. Your expertise will help guide product development and ensure compliance throughout the product lifecycle, making a significant impact on global health.
Key Responsibilities
Develop regulatory CMC strategy for assigned products
Compile information for regulatory CMC strategy
Maintain Regulatory CMC Strategy Document
Contribute to Global Regulatory Product Strategy
Prepare and coordinate regulatory submissions
Manage contacts with regulatory agencies
Provide regulatory guidance to project teams
Required Qualifications
Earned 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
Strong organization skills
Concise and persuasive communication skills
Strong Regulatory knowledge
Preferred Qualifications
Masters degree
Foundational understanding of Artificial Intelligence
Strong background in drug development, manufacturing, or testing
Proficient in MS Word, Excel, PowerPoint
Demonstrated ability to work successfully on global project teams
Benefits & Perks
High-quality healthcarePrevention and wellness programsAt least 14 weeks’ gender-neutral parental leave