Speakers

Associate Vice President of Manufacturing Science & Technology Group (MSTG), Regulatory & Business Continuity, and US Agent at Sun Pharmaceutical Industries Inc. (Sun Pharma).

Umesh leads the development and design of processes for solid and liquid oral dosage forms, supporting technology transfer, registration batches, process qualification, and lifecycle management at Sun Pharma’s US site. Umesh also provides regulatory support for operations, including the filing of new applications and lifecycle management of generic drug products for the U.S. market. As the designated US Agent, he facilitates engagement with the U.S. FDA, for new submissions, regulatory reviews, lifecycle activities, and drug shortage mitigation.

He holds a Master’s in Pharmaceutical Sciences from University Department of Chemical Technology (UDCT), Mumbai. With over 25 years of experience in the pharmaceutical industry, Umesh has specialized in R&D, Technical Services, Regulatory Affairs, and Business Continuity.