Kavita Aiyer

Seagen Inc.

Dr. Kavita Ramalingam Iyer is the Regulatory CMC Team and Program Lead for the oncology program within Global Regulatory Affairs Organization at GSK. She has more than 11 years of Pharmaceutical industry experience leading vaccines manufacturing, process development, establishment of GMP facilities, vaccines and biologics technology transfer, talent development and strategic initiatives and performed site audits. During her time at Merck & Co., Inc. she held positions of responsibility for multiple programs and product portfolios including novel mRNA therapy and combination products that cover investigational and commercial space across vaccines and biologics. Kavita is a certified lean six sigma black belt and has championed significant process improvements through employment of Kaizen, six sigma and lean principles. In her current role as a regulatory professional Kavita is responsible for managing end to end product dossier life cycle activities investigational, initial registration & post approval phases; 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 also serves as a GSK Regulatory CMC representative in the industry form 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 ANVISA and presented on complexity and impact of post approval changes. Recently she was inducted as a CASSS Associate Director.
Kavita graduated with a Ph.D in Biotechnology from Anna University, India and pursued here post-doctoral research at University of Minnesota focusing on antibody engineering and synthetic biology prior to joining Merck.