Position Overview
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 discussions are anticipated.Develop constructive relationships with and proactively escalate potentially critical issues to key internal and external stakeholders, including Alliance Partners.Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines and provide guidance to direct reports and all group members for their training and developments.Lead a group of individual...