Senior Director Regulatory Affairs CMC
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
We are looking for a Senior Director of Global Regulatory Affairs CMC to join a leading pharmaceutical organization in the Greater Philadelphia area.
The Senior Director, Global Regulatory CMC will be responsible for:
- Oversee Global Health Authority interaction related to Regulatory CMC matters/inquiries
- Represent the Regulatory CMC function in cross-functional meetings and collaborative work
- Manage Regulatory CMC strategies for full life cycle development of biologic products
- Review technical aspects of global submissions including but not limited to- IND, BLA, MAA
The Senior Director, Global Regulatory CMC should have the following qualifications:
- 10-12 years of Global Regulatory CMC experience
- At least 5 years experience in Biologics
- Background supporting teams cross-functionally (Manufacturing, Quality, Regulatory Strategy/Operations, etc.)
- Currently hold a title within Regulatory Affairs CMC pertaining to biologic products
If you are interested in this opportunity, please apply here.
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