Dr. Rupali Abhijit Kulkarni

Dr. Rupali Abhijit Kulkarni currently holds the position of Senior Manager in Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA CMC) at Alvotech, specializing in dossier preparation and review for monoclonal antibody registrations and post-approval submissions. Prior experience includes a managerial role at Biocon Biologics, where responsibilities encompassed writing and reviewing regulatory dossier sections and coordinating submissions across regions. Dr. Kulkarni has also served in various roles in other pharmaceutical companies, including Intas Pharmaceuticals and Wockhardt Ltd., focusing on project facilitation, regulatory compliance, and analytical methodologies. With an academic background including a Ph.D. in Microbiology, Dr. Kulkarni's extensive expertise spans multiple facets of regulatory affairs and biopharmaceutical development.