Dr. Li is an accomplished regulatory affairs professional with over three decades of experience in pharmaceutical development and regulatory affairs. She has held leadership positions at Novartis, Alcon, and Bausch & Lomb, where her contributions encompass health authority interactions, U.S. Food and Drug Administration advisory committee meetings, and guiding regulatory teams.
Dr. Li’s significant achievements include her pivotal role in securing FDA approvals for numerous ophthalmology products, including Jetrea, Lotemax Ointment, and Systane Complete. She also contributed to the development and registration of critical medicines, including Beovu, Pazeo, Lotemax Gel, Besivance, and Vyzulta.
Dr. Li received a Regulatory Affairs certification in 2005. She possesses a comprehensive skill set that spans various pharmaceutical domains including expertise in Chemistry, Manufacturing, and Controls, clinical development, product labeling, advertising and promotion.
Dr. Li earned her Ph.D. in medicinal chemistry from China Pharmaceutical University.