Director, Therapeutic Area Head Of China Regulatory Strategy, Neuroscience, R&d, Beijing

Takeda UK

Beijing, China
China regulatory requirements
Drug development strategy
Product registration and lifecycle management
Responsible for providing strategic regulatory inputs into drug development and oversight of registration, life-cycle management and maintenance of Takeda's pipeline and marketed products for assigned therapeutic area (TA)

Job Summary

  • Responsible for providing strategic regulatory inputs into drug development and oversight of registration, life-cycle management and maintenance of Takeda's pipeline and marketed products for assigned therapeutic area (TA).
  • Develops and implements progressive regulatory strategies, ensures compliance with regulatory requirements, and manages interactions with regulatory authorities for assigned products.
  • Provides inspirational leadership and growth opportunities for direct reports, empowering them to design and execute impactful regulatory strategies in close collaboration with R&D and Business partners.

Matching Summary

Responsible for providing strategic regulatory inputs into drug development and oversight of registration, life-cycle management and maintenance of Takeda's pipeline and marketed products for assigned therapeutic area (TA).

Skills & Requirements

Must-have

  • China regulatory requirements
  • drug development strategy
  • product registration and lifecycle management
  • regulatory authority interactions

Nice-to-have

  • cross-functional initiative leadership
  • team empowerment and development
  • shaping regulatory field

Key Requirements

  • Bachelor’s degree or above majored in medicine or pharmacy
  • 15 years of related work experience in regulatory affairs
  • 5 years of experience in people management
  • In-depth knowledge of China regulatory requirements including Psychotropic Regulation

Work Rights

Not specified

Tailored Resume

Cover Letter