Dr. Li is an accomplished regulatory affairs professional with over three decades of experience in pharmaceutical development and regulatory affairs. She held leadership positions at Novartis, Alcon, and Bausch & Lomb, where her contributions encompassed health authority interactions, US 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 PhD in medicinal chemistry from China Pharmaceutical University.