CMC Regulatory Science Expert  / Non Line Manager / Regulatory Science Expert Group CMC Dept

**Basic Purpose of the job:**


This position is responsible for preparing and reviewing CMC relevant documents as well as assessing and mitigating risks on clinical trials and NDA in Japan for New Molecular Entity projects in accordance to all applicable latest regulatory requirements and science (ICH, cGMP, SOPs, etc.) as well as in a proactive collaboration and coordination with BI partners.


This position is assigned as Dev JP TA rep and is responsible for mitigating CMC relevant risks on clinical trials and NDA in Japan by communicating with both global and local project teams.

**Accountabilities - Related Performance Indicators:**

Author and review all the CMC relevant documents for regulatory submission (e.g. CTD, IB, etc) in accordance to all applicable guidelines and regulations (ICH, cGMP, SOPs, etc.) as well as the state of the art science


-Author and review the Common Technical Document (CTD), I.B. for quality section...