24 years working experience in pharmaceutical industry including drug development, regulatory/registration, patent protection, manufacturing and quality operations, strategical and business development, and operation managementHands-on experience in drug substance, drug product and analytical development, and CMC dossier preparationExtensive experience in developing technical sound and compliant CMC dossiers for fast CTA and NDA/BLA approvals in China Proven record in successful working with CDE, NIFDC, and ChP to solve challenging CMC issues for the company and IndustryClose working relationship with CFDA in development of China new CMC regulations, guidelines, and training programsWorking experience in global submissions for a broad product category including small molecule, mAb, and CAR-T In-depth knowledge in excipient science and regulations. Chair of Pfizer Excipient Chemistry NetworkSolid training in organic chemistry and analytical chemistry