Regulatory Affairs Director

GE HealthCare UK

Beijing, China
Develop regulatory strategies for innovative drugs in china
Submit ind and nda applications
Work closely with healthcare regulatory bodies in china
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally

Job Summary

  • Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally.
  • Develop regulatory strategies for innovative drugs in China, including the submission of IND (Investigational New Drug) and NDA (New Drug Application).
  • GE HealthCare is a leading global medical technology and digital solutions innovator.

Matching Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally.

Skills & Requirements

Must-have

  • develop regulatory strategies for innovative drugs in China
  • submit IND and NDA applications
  • work closely with healthcare regulatory bodies in China
  • communication with regulatory authorities
  • execute policies and strategies
  • lead a small team
  • assess impact on business and regulatory strategies

Nice-to-have

  • turn ideas into world-changing realities
  • fosters care, collaboration and support
  • unlock your ambition

Key Requirements

  • Bachelor's degree or above
  • 10-15 years regulatory experience
  • 3+ years nuclear medicine experience
  • People management experience
  • Strong oral and written communication skills
  • Effective communication and collaboration

Work Rights

Not specified

Tailored Resume

Cover Letter