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

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 individuals to support group’s goals according to agreed timelines, standards and business priorities. 日本における医薬品（化学合成品、バイオ医薬品）の新規申請及び承認取得後のCMC薬事に関連する下記業務に責任を持つグループの責任者。申請戦略・申請計画のCMCパートについて立案・遂行。薬事関連の当局相談に係る戦略策定及び遂行。製造販売承認申請業務（CMCパート）。導入案件のCMC薬事関連の評価。グループメンバーの教育訓練及び人財育成。