Director, Japan CMC & Devices Regulatory Affairs, New Drug Application Group
Takeda Pharmaceutical Company(4 months ago)
About this role
Director-level leader of the Japan CMC & Devices Regulatory Affairs New Drug Application group at Takeda, accountable for the group's role in regulatory CMC activities across drug development and lifecycle in Japan. The role is based in Takeda Development Center Japan and works closely with global development, manufacturing partners, and regulatory authorities. Position is full-time with office locations in Osaka or Tokyo.
Required Skills
- CMC
- Regulatory Strategy
- NDA Submissions
- Health Authority Negotiation
- Stakeholder Management
- Team Leadership
- GMP
- Change Management
- Cross-Functional Collaboration
- Communication
Qualifications
- Bachelor Degree (Science)
- Master's Degree Preferred
- TOEIC 750+
About Takeda Pharmaceutical Company
takeda.comTakeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
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