💼 Full-Time Position

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

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Takeda
📍 Osaka, Osaka, Japan
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Location
Osaka, Japan
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Posted
June 21, 2026
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Type
Full-Time
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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.

Job Description

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...