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

Takeda

Osaka, Japan
Leadership in regulatory affairs
Experience with cmc regulations
Communication with health authorities
Lead the Japan CMC & Devices RA New Drug Application group to fulfill regulatory responsibilities

Job Summary

  • Lead the Japan CMC & Devices RA New Drug Application group to fulfill regulatory responsibilities.
  • Oversee development and execution of regulatory CMC strategies for clinical development and NDA approval.
  • Contribute to delivering medical products to patients in Japan, enhancing skills in regulatory processes.

Matching Summary

Lead the Japan CMC & Devices RA New Drug Application group to fulfill regulatory responsibilities.

Skills & Requirements

Must-have

  • Leadership in Regulatory Affairs
  • Experience with CMC regulations
  • Communication with Health Authorities

Nice-to-have

  • Ability to build relationships
  • Experience in international environments
  • Proactive issue escalation

Key Requirements

  • 10+ years of experience in pharmaceuticals
  • Expertise in drug development and approval processes
  • Business-level Japanese and English communication skills

Work Rights

Not specified

Tailored Resume

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