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工作地点在北京国贸地区。汇报给公司的CMO,注册总监要负责带领北京和成都的注册团队负责产品的NDA。
作为药政事务部负责人,全面负责公司所有产品大中华区域的监管事务活动,以及综合管线产品全球的监管事务活动,提供监管战略产品方向,与CDE, FDA, EMA等监管机构进行互动和协商。
作为集团注册总监,负责组建注册团队;负责与各大型检测机构,第三方合作公司,以及国家注册局方等保持紧密的沟通和合作;建立注册平台统筹资源,对内赋能,对外资源对接。
根据公司产品规划,安排注册进度,负责督导产品注册全过程 ,负责起草、编制标准化文件,确认并提交注册申请。
The Drug Discovery Lead will be tasked with leading the development of operations in this exciting field and the development of a new drug discovery portfolio.
This role acts as a strategic communications business partner to the deployed business unit leadership and teams.
Based in Nanjing or Hangzhou, this role will manage 20 people in Biology, pharmacology , translational study, DMPK and tox. This role will report directly to CEO and the Board director.
ADC Production Head