Kavita Ramalingam Iyer, PhD MSD

Dr. Ramalingam Iyer 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 MSD in 2008.

Kavita has more than 8 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 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.