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, EMA, and PMDA etc., review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure GXP compliance of all development activities in accordance with the US, EU, JP, and ICH regulations and guidelines

Basel, Baselstadt, Ch

New York, New York, Us

Ph.D., Pharmaceutics

Ms, Bs, Department Of Intensive Instruction