Ronak Gandhi
CMC Regulatory
- Role
- Senior Scientist, Cmc Regulatory at Vanda Pharmaceuticals
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Ronak Gandhi
Regulatory CMC professional with 17+ years of combined academic and pharmaceutical industry experience, including 11+ years focused on CMC. Brings deep expertise in global regulatory submissions and lifecycle management across INDs, IMPDs, NDAs, MAAs, BLAs, and Annual Reports for small molecules and biologics, including monoclonal antibodies, antisense oligonucleotides, and plasma-derived products. Known for translating complex technical, manufacturing, and quality information into clear, compliant regulatory strategies that support development through commercialization. Effective cross-functional leader and partner to internal teams, CROs, and CDMOs, with a strong track record of driving submission readiness, regulatory documentation, and global CMC execution.
Experience
Senior Scientist, Cmc Regulatory
Feb 2023 — Present · Washington, DC, US
Education
The Maharaja Sayajirao University of Baroda
Bachelor's degree
2004 — 2008
University of Illinois at Chicago
Doctor of Philosophy (PhD)
2010 — 2016
Virginia Commonwealth University
Master's degree
2008 — 2011
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