Li Wan, Ph.D, Rac Email & Phone Number

• Develop and implement the global regulatory strategies to ensure the efficient clinical development and regulatory filings of innovative ADC products in GeneQuantum pipeline
• Lead regulatory interactions/negotiations with the global regulatory agencies and responsible for all regulatory communications and submissions in the United States, China, and globally
• Build and manage the Global Regulatory Affairs team, providing regulatory leadership and support to project teams throughout the drug development process in clinical, nonclinical, and CMC activities
• Oversee internal/external development efforts to ensure compliance with GLP, GCP, and GMP standards and international regulations

苏州市, 江苏省, CN

• Lead the development of the global regulatory strategy and clinical development plan for innovative bispecific antibodies in Alphamab Immuno-oncology pipeline for multiple cancer indications in the US and China
• Oversee the preparation and filing of all regulatory submissions from IND to BLA including PIND meeting request and package, DSURs, Fast Track, Orphan Drug, and Breakthrough Designation to FDA/NMPA
• Act as US agent, drive regulatory interactions/negotiations, and foster a strong relationship with FDA
• Build the Regulatory Affairs team and manage internal/external regulatory operation personnel to provide high-level strategic leadership and operational excellence to all project teams

Shanghai, CN

Lead the Global Regulatory Affairs to advance the clinical development of all Luye R&D projects in the United States, Europe, Japan, and etc., Responsible for development of the global regulatory strategy and manage the preparation and filing of regulatory applications (IND/CTA, NDA/BLA/MAA), communicate with International Health Authorities including FDA.

Basel, Baselstadt, CH

New York, New York, US

Ph.D., Pharmaceutics

Ms, Bs, Department Of Intensive Instruction