Director, Japan CMC & Devices Regulatory Affairs, New Drug Application Group

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**Job Description**

As a leader of Japan CMC & Devices RA New Drug Application group, lead the group to fulfill expected roles and responsibilities according to Global RA vision/mission and Company’s vision/mission/value.

+ Oversee the development and execution of regulatory CMC development and registration strategies of all assigned products throughout clinical development and NDA approval.
+ Successfully communicate and negotiate with Health Authorities as necessary, directly and indirectly, especially when difficult discus...