Dr. Harshad Kothawade

Dr. Harshad Kothawade is a seasoned professional in regulatory management and trade compliance, currently serving as the Director and Head of Regulatory Management & Trade Compliance for India, South East Asia, and ANZ at Merck Group since December 2013. With extensive experience in regulatory affairs, Dr. Kothawade has successfully led various strategic projects, managed submissions for IND/NDA and EU submissions, and interfaced with multiple cross-discipline teams across marketing, operations, and regulatory units. Dr. Kothawade's expertise encompasses clinical research, regulatory compliance, and custom compliance, with a strong track record in eCTD submissions and lifecycle management of pharmaceutical products. Prior roles include managerial positions in regulatory affairs at Famy Care Limited, JB Chemicals & Pharmaceuticals, and Inventia Healthcare, complemented by an academic background with a PhD in Pharmaceutical Sciences and an International Management Program from Merck University.