Regulatory Affairs Director

GE HealthCare

Develop regulatory strategies for innovative drugs in china
Work closely with healthcare regulatory bodies globally
Communicate and collaborate effectively with cross-departmental teams
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).
  • Lead a small team, mentor colleagues with less experience, and drive consensus within the team on relevant topics.

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
  • Work closely with healthcare regulatory bodies globally
  • Communicate and collaborate effectively with cross-departmental teams

Nice-to-have

  • Unlock your ambition
  • Turn ideas into world-changing realities
  • Foster care, collaboration and support

Key Requirements

  • Bachelor's degree or above in pharmacy, medicine, biology, or related fields
  • At least 10-15 years of regulatory experience in the pharmaceutical industry
  • 3+ years in the field of nuclear medicine, particularly innovative drugs
  • People management experiences

Work Rights

Not specified

Tailored Resume

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