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Abhijit P. Pangu, M. Pharm, RAC

VP, Regulatory Affairs
Pharnext

20+ years experience in the pharmaceutical industry with a focus on Regulatory Affairs Strategy Development, Project Management, and Pharmaceutical Development.
Successfully developed and implemented regulatory strategies leading to pre-IND/developmental activities (EOP2/pre NDA), CMC technical writing, FDA meetings (Type A, B and C), global eCTD NDA/MAA submissions, lifecycle post-approval submissions, and late-stage labeling discussions.
Experience across various Divisions of FDA including Anti-infectives, Neurology, Urology/Reproductive Health, Metabolism, Gastroenterology, Oncology, CBER (Gene Therapy), and Orphan Products Development.
Currently heading RA at Pharnext SA since 2021.

Disclosure information not submitted.

Presentation(s):