Mike Cooper
Regulatory Affairs Professional for the Biopharmaceutical Industry
- Role
- Director, Nonclinical and Cmc Regulatory Affairs at Ssi Strategy
- Location
- Nashua, NH, US
- LinkedIn followers
- 500 followers
About Mike Cooper
As a Director of Regulatory Affairs at SSI Strategy, I author Regulatory Affairs…
Experience
Director, Nonclinical and Cmc Regulatory Affairs
Jan 2025 — Present · Parsippany, NJ, US
Support biologic and small molecule clients in: preparation and maintenance of INDs for biologics and small molecules; coordinate responses to agency Information Requests; perform CMC gap assessments; author CMC documents for BLAs and MAAs for biologic, biosimilar, and combination products; and post-approval lifecycle maintenance for the US, EU, Japan, Malaysia, and South Korea.
Education
University of California, Berkeley Extension
Professional Program in Regulatory Affairs
Carnegie Mellon University
B.S.
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