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13+ years experience

Sanjay Patil

Faculty Lead — Regulatory Affairs

Sanjay leads the Regulatory Affairs curriculum at iLearn CRI, drawing on thirteen years across Lupin, Glenmark, and a Pune-based regulatory consulting boutique. He has personally compiled 60+ ANDAs, 25+ DMFs, and led EMA marketing authorisation submissions for biosimilars portfolios.

He teaches the regulatory module from current work — recent FDA Form 483 responses, active variation submissions, current CDSCO SUGAM filings — ensuring students learn the regulatory landscape as it actually is in 2026, not the framework that was taught a decade ago.