Sanofi
GRA-CMC Lead Small Molecule
Morristown, NJ
Sponsorship not specified$122k-$177kDetected 1 day ago
Product ManagementFDA RegulatoryMedical DevicesCommunicationCollaborationRegulatory Affairs
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33Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
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About the role
- About Sanofi: We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth.
- Together, we chase the miracles of science to improve people's lives.
Responsibilities
- Develop and implement global regulatory CMC strategies for both development and marketed small molecule products, executing and adapting them to meet evolving regulatory and business needs
- Act as direct liaison with agencies such as the US FDA and EMA, build positive relationships and supporting strategic negotiations worldwide
- Lead cross-functional collaboration with R&D, Manufacturing & Supply, and Regulatory Operations teams to ensure effective implementation of regulatory strategies and timely resolution of CMC issues
- Lead high-impact regulatory strategies for global development and marketed products, directly influencing the approval and success of life-changing treatments
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Requirements
- Fluency in English is required
- Ability to thrive in fast-paced settings across multiple product lines
Skills
- Job title: GRA-CMC Lead Small Molecule
- Morristown, NJ
- About the job
- Ready to get started?
- Our GRA-CMC department ensures compliance while optimizing product approval pathways across the product lifecycle.
- Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research.
- Soft and technical skills
- Excellent communication skills (concise, informative, and persuasive)
Compensation
- $122,250.00 - $176,583.33
- All compensation will be determined commensurate with demonstrated experience.
Benefits
- Bachelor's degree in a scientific discipline required; advanced degree (Masters or PhD) in a science, health-related and/or regulatory field is preferred.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Company info
- We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth.
- Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products.
Equal opportunity
- Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce.
Visa & Work Authorization
- ual opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity
This listing is sourced directly from Sanofi's careers page and normalized into a canonical job model.