Li RAC’s Email & Phone

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Li RAC

Vice President, Head of Global Regulatory Affairs @ Luye Pharma Group

Li RAC Contact Details

Location:
Princeton, New Jersey
Work:
Vice President, Head of Global Regulatory Affairs @ Luye Pharma Group
Global Regulatory Project Lead, Global Regulatory Affairs (GRA) @ Novartis
Senior Scientist, Pharmaceutical Sciences, Pfizer Global R&D @ Pfizer Pharmaceuticals
Education:
MS, BS @ Nanjing University
About:

Regulatory affairs manager with in-depth understanding of the regulatory strategy development, pre- and post-approval regulatory guidelines and global submission requirements. A working knowledge of regulatory review and approval processes in the US, EU, JP and China etc. major global markets (IND/IMPD/CTA/NDA/MAA). Proficient in regulatory dossier management, dossier strategy and content development, NeeS and eCTD submissions. Proven record 

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