Ashutosh Jaiswal

Background

About Ashutosh Jaiswal

Regulatory affairs, Regulatory CMC, Program Regulatory Management professional with 18+ years of experience with continuous gain in expertise in Small molecules, Cell/Gene therapy products (ATMP), Established products (Marketed brands & Generics for Stringent regulatory markets like EU and US and Most of the World markets. Leading the cross-functional regulatory sub team and representing regulatory in Global Program Team (GPT) for assigned product and develop regulatory strategy support to the several types of submissions like Clinical Trial Applications, Briefing Book Preparation, SEED, Target Product Profile Preparation, Clinical Development Plan, Protocol Preparation, Regulatory Functional Plan, Risk Management Plan, Investigator Brochure, Pediatric Indication Plan, Protocol Amendments, New Drug Application, Marketing Authorization Application, Supplements, 505(b)(2) applications and Generics, Post-approval submissions & Life cycle management submissions like Variations, Production Transfers, HA responses, Renewals, Supplements, Annual reports, change management & Line extensions all from global perspectives. Proven skills working in matrix teams & in developing and leading Global/ Regional Regulatory Program/ Project including budget accountability, allocations, reporting, execution and completion as per the agreed Global Program timelines.