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Kavita Ramalingam Iyer, Ph.D.

Associate Director, Global Regulatory Affairs and Clinical Safety - CMC Vaccines at Merck Sharp & Dohme Corp.

Profile

Dr. Kavita received her Ph.D in Biotechnology from Anna University, India and completed post-doctoral fellowship at University of Minnesota, USA focusing on antibody engineering and synthetic biology prior to joining Merck in 2008.

 Kavita has more than 9 years of Pharmaceutical industry experience leading CMC development, manufacturing, establishment of GMP facilities, technology transfer, talent development and strategic initiatives and performed site audits. She is a certified lean six sigma black belt. Currently, Dr. Kavita Ramalingam Iyer is the Regulatory Lead for investigational and marketed vaccine and biologics products within Global Regulatory Affairs and Clinical Supply (GRACS) Organization. Her current responsibilities include managing product dossier life cycles; developing, shaping and implementing CMC regulatory strategies in compliance with global regulations, developing regulatory documentation to support worldwide registration, lead regulatory CMC representative on matrix teams and mentors early development and cross-functional teams. She serves as a Merck Regulatory CMC representative in the industry group called BioPhorum Operations Group (BPOG); has given several conference talks and published multiple position papers in collaboration with industry experts addressing emerging regulations and guidance documents covering product development, registration and post-approval changes. She was one of the BPOG delegates who recently interacted with health agency in Latin America to discuss complexity and impact of post approval changes.

Agenda Sessions