Responsibilities:
Implementation registration strategy for new drugs an******** products
Partner with other functional teams to support the regulatory strategydevelopment an********, implement effectively the regulatory strategiesfor registration of new products an******** trial appl******** whererequired
Ensure optimum execution of RA registration strategies an********activities with cross-functional representatives
Critically analyze data packages for regulatory compliance an********discrepancies in data presente******** request additional data
Provide strong regulatory supports on business development opportunitiesan********
Partner with CMC an********-Clinical for the implementation China GMP,Chinese Pharmacopeia (CHP) an******** China regulatory requirements inmanufacturing sites as well as the GMP inspections regarding productquality control if necessary
Lea******** responses preparation to deficiency letters an******** thatthese an******** data requirements are submitte******** regulatoryagencies within the stipulate******** agree********
Provide regulatory supports on b******** tender an******** businessactivities
Ensuring Regulatory Compliance
Ensure timely communicate the China regulations requirements to internalstakeholders to facilitate the implement of China regulations in dailyoperations an******** manufacture sites
Ensure the daily operations is in light with company SOPs an********