Debashish Bhattacharya
- Role
- Associate Director Regulatory Affairs (Cmc) at Ultragenyx
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
Experience
Associate Director Regulatory Affairs (Cmc)
Jun 2021 — Present · CA, US
Spearheaded the CMC regulatory strategy for multiple complex drug development programs, leading to the successful approval of 1 mRNA and 1 mAb CMC dossier (CTA). Oversaw the preparation, submission, and lifecycle management of all CMC sections of regulatory dossiers (IND and MAA) to global health authorities (FDA, EMA, etc.). Collaborated cross-functionally with R&D, Quality Assurance, Manufacturing, and external stakeholders to ensure alignment with regulatory requirements and timely submissions.
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