Kaia Agarwal, MSc

Kaia Agarwal is an independent regulatory consultant who works with PharmApprove. Kaia has over 27 years of global leadership experience in the pharmaceutical and biotechnology industry, and strategic regulatory expertise across CMC and Clinical Development. She has led teams preparing for global filings, FDA PDUFA meetings, EU national and CHMP Scientific Advice meetings, FDA Advisory Committee Meetings, and CHMP Oral Explanation Hearings. Kaia has extensive experience in the development and registration of several small molecules, vaccines and biologic products across all major therapeutic areas and regions, including Cardiovascular, Endocrine, CNS, Pain, Immunology, Oncology, Antivirals, and Vaccines. She was most recently the VP and Global Head Regulatory Affairs, Novartis Vaccines and Diagnostics and previously was the Divisional VP, Development Regulatory Affairs, Abbott; VP of Regulatory Affairs, Genzyme and various roles of increasing responsibility with GlaxoSmithKline and Sanofi Aventis (formerly Connaught Labs Ltd). Kaia holds a M.Sc. in Microbiology from University of Toronto, Canada.