Job Description
**Job title:** GRA CMC Lead
+ **Location:** Morristown, NJ
**About the job**
As **GRA CMC Lead** within our **R&D team** , you will shape and lead global regulatory CMC strategies for both development and marketed small molecule products, working at the intersection of science, regulation, and innovation to bring life-changing medicines to patients worldwide. Within Sanofi's Global Regulatory Affairs CMC organization, this role serves as a critical strategic partner, bridging the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways across the product lifecycle.
In this role, you will develop and implement global regulatory CMC strategies, act as direct liaison with agencies such as the US FDA and EMA to build positive relationships and support strategic negotiations worldwide, and prepare, review, and approve regulatory CMC dossiers ensurin...
+ **Location:** Morristown, NJ
**About the job**
As **GRA CMC Lead** within our **R&D team** , you will shape and lead global regulatory CMC strategies for both development and marketed small molecule products, working at the intersection of science, regulation, and innovation to bring life-changing medicines to patients worldwide. Within Sanofi's Global Regulatory Affairs CMC organization, this role serves as a critical strategic partner, bridging the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways across the product lifecycle.
In this role, you will develop and implement global regulatory CMC strategies, act as direct liaison with agencies such as the US FDA and EMA to build positive relationships and support strategic negotiations worldwide, and prepare, review, and approve regulatory CMC dossiers ensurin...