Harshad Kothawade PhD

Dr. Harshad Kothawade is the Director and Head of Regulatory Management and trade Compliance at Merck India. He is accountable for India’s Regulatory Compliance activities including Regulatory Affairs, Regulatory Management, Trade Compliance, and Import and Export operations. Harshad has a Doctorate in Pharmacy (Pharmaceutical science, Masters in Pharmacy & MBA from Pune University, India. Harshad has 15 years of experience in Regulatory Management and t-trade compliance in the Pharmaceutical/Life Science Industry. Expertise in all Regulatory and compliance activities for countries like the US, EU, CA & ROW including the Indian Market.

His prime focus is to make Regulatory & Trade Compliance function as a business enabler & change the entire business perspective towards Regulatory & Trade Compliance by interpreting, implementing & adapting Indian regulations from a business perspective in a compliant way. In Merck, he has led significant progress in the development of a Regulatory Compliant culture, established full-proof Regulatory Management System document, and improved delivery performance in International Inbound and Outbound. This has resulted in Significant Business Impact in terms of Supply Chain Cost savings and additional revenue by solving problems and capturing opportunities.