Head Of Regulatory Affairs, R&d, Shanghai/beijing

Takeda UK

Shanghai, China
Strategic regulatory inputs
Drug development oversight
Registration and life-cycle management
The Vice President, Head of Greater China Regulatory Affairs is 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

Job Summary

  • The Vice President, Head of Greater China Regulatory Affairs is 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.
  • Lead the regulatory strategy team to develop and execute innovative regulatory strategies enabling product approval, including challenging timeline and life-cycle management with predictability, cross-functional collaboration and flawless execution.
  • In partnership with Global Regulatory Policy and Innovation, shape the external environment by proactively engaging with Regulatory Authority (i.e. CDE), industry organizations (i.e. RDPAC), and key stakeholders to influence evolving regulations and standards.

Matching Summary

The Vice President, Head of Greater China Regulatory Affairs is 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.

Skills & Requirements

Must-have

  • strategic regulatory inputs
  • drug development oversight
  • registration and life-cycle management
  • compliance with regulatory requirements
  • interactions with regulatory authorities
  • leading regulatory strategy team

Nice-to-have

  • fostering high-performance environment
  • shaping external regulatory environment
  • driving thought leadership
  • anticipating industry trends

Key Requirements

  • 12+ years of regulatory affairs experience
  • 10+ years in people/team management
  • Bachelor’s degree in life sciences
  • In-depth knowledge of global and local regulatory requirements
  • Experience working in a global environment

Work Rights

Not specified

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