Sharad Agarwal
CMC Regulatory Affairs
- Role
- Regulatory Affairs Cmc - Head of Large Molecule Development at EMD Serono, Inc.
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
Experience
Regulatory Affairs Cmc - Head of Large Molecule Development
Jul 2021 — Present
Education
Rutgers University
Molecular Biology and Biochemistry
2001 — 2005
Skills
- 21 Cfr Part 11
- Regulatory Requirements
- Regulatory Submissions
- Technology Transfer
- Validation
- Gmp
- Capa
- Quality System
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Affairs
- Design Control
- Biotechnology
- Cmc Regulatory Affairs
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