职位详情

(高级)注册经理

面议

北京东城区 3-5年 本科
江苏恒瑞医药股份有限公司

医药企业 其他 规模不详

职位描述
  • 五险一金
  • 节日福利
  • 带薪年假
  • 晋升机会
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********
职位要求
  • 专业要求: 药学,中医学与中药学
  • 最低学历: 本科
  • 工作年限: 3-5年
  • 职称要求: 不限
  • 英语等级: 英语六级
  • 招聘人数: 1
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