HARSHAD KOTHAWADE, Former Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ, Merck Group

•   Associated with Pharmaceutical & Life Science Industry Since 2006, started as formulation development scientist & since 2007 hard core Regulatory affairs' activities.

•   Well versed with general procedures as a part of Global Regulatory Affairs, general compliance & conduct of Multinational companies with Global Regulatory Authorities

•   I am a proactive and achievement-oriented professional offering over 16 years of rich experience in Regulatory Compliance, Trade Compliance, and Imports & Export Operations, responding to queries, dossier, documentation, enhancing operational efficiency while reducing the cycle time.

•   Currently associated with Merck Group as Director/ Head of Regulatory Management & Trade Compliance, Global Regulatory Affairs and Integrating the regional knowledge throughout the product lifecycle with aspects of effective management and strategy development.

•   I am a forward thinking person with proficiency in implementing Government Affairs strategies, playing a pivotal role as the representative like IPEC, FICCI, ISPE India Affiliate, PDA India, Chemexcil, RX 360 etc., Regulations and guidance governing drugs during development and validations including post-marketing, in the US/EU, ROW & Emerging Markets, E CTD, Minitab 14, Statistica, IBM SCORE, Take Solution, RIMS VEEVA Vault, Educe, Educe SPL, InDesign Software for Actual Labeling Preparation, SAP – Global Trade Service (GTS) and paper CTD submissions including Dossier Management by Educe Solutions, IBM SCORE, ECTD Express by ISI Regulatory Solutions.