Sr. Manager Of Regulatory Affairs Cmc

Lilly

Master degree in pharmaceutical sciences
7+ years drug development experience
3+ years global pharma company experience
The role involves independently driving new product registrations and life-cycle maintenance from a CMC perspective for a global healthcare leader

Job Summary

  • The role involves independently driving new product registrations and life-cycle maintenance from a CMC perspective for a global healthcare leader.
  • Candidates must interpret China-specific regulations and directly communicate with the National Medical Products Administration (NMPA) on complex technical issues.
  • The position requires serving as a subject matter expert to influence global teams and shape the regulatory environment through industry platforms.

Matching Summary

The role involves independently driving new product registrations and life-cycle maintenance from a CMC perspective for a global healthcare leader.

Skills & Requirements

Must-have

  • Master degree in pharmaceutical sciences
  • 7+ years drug development experience
  • 3+ years global pharma company experience
  • Full NDA/BLA project submission to approval
  • China regulations and ICH guidance knowledge

Nice-to-have

  • Experience with ADC gene or cell therapy
  • Knowledge of FDA and EMA regulations
  • Experience with novel therapeutic modalities
  • Strong English communication skills
  • Ability to shape regulatory environment

Key Requirements

  • Master degree required
  • Minimum 7 years experience
  • Minimum 3 years global pharma experience
  • Hands-on NDA/BLA submission experience
  • Fluency in English required

Work Rights

Not specified

Tailored Resume

Cover Letter