Director, Japan Cmc & Devices Regulatory Affairs, New Drug Application Group
Takeda
Osaka, Japan
Japan cmc & devices ra
New drug application group
Regulatory cmc development
Oversee the development and execution of regulatory CMC development and registration strategies of all assigned products throughout clinical development and NDA approval
Job Summary
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.
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.
Matching Summary
Oversee the development and execution of regulatory CMC development and registration strategies of all assigned products throughout clinical development and NDA approval.
Skills & Requirements
Must-have
Japan CMC & Devices RA
New Drug Application Group
regulatory CMC development
registration strategies
communicate and negotiate with Health Authorities
global RA CMC regulations and guidelines
Nice-to-have
proactively escalate potentially critical issues
constructive relationships
new drug development
international perspective
challenge new things
Key Requirements
10+ years of experience in pharmaceutical R&D, manufacturing, or testing
Knowledge of drug development and approval application processes
Experience with regulatory procedures for post-marketing changes
Experience in meetings and consultations with Japanese regulatory authorities
5+ years of experience in organizational management and talent management
Business level Japanese and English communication skills