工作職責(zé)?1.Strategy: Form China development strategy map/decision tree for development portfolio including HA meeting strategy for pre IND, end of Phase II, pre NDA and DMF; NDA strategy including label, manufacturing source to optimize speed of approval, price and reimbursement negotiation etc. Form aligned China reflection paper to guide regulatory sub function s understanding and input to development and marketed portfolios to the new requirements trigged by the new and revised local technical guidance and regulations. Organize project deep drive at China RA department level to refine and align regulatory strategy for both development and marketed portfolio, ensure the execution of the defined strategy Ensure and provide optimal Regulatory strategy input for DD of in licensing activity in China 2.Compliance: To be responsible for 100% regulatory compliance to both health authority requirements and company internal policy. E.g.? pre approval GCP and GMP inspection, annual report, promotional material LMR review, etc., 3.Efficiency excellence: As a backbone function for China RA, RCE focus on efficiency excellence to ensure maximize regulatory business outcome via exploring digital innovation tools. Focal point to provide comments and suggestions to global SOP and ensure its implementation in China RA. Creation, revision and retirement of local SOP for China RA and R