Sr. Manager Of Regulatory Affairs Cmc

Eli Lilly UK

Not specified
Master degree in pharmaceutical sciences
7+ years drug development experience
3+ years global pharma company experience
Eli Lilly UK is seeking a Sr. Manager of Regulatory Affairs CMC, an individual contributor responsible for managing product registrations and lifecycle maintenance from a CMC perspective. The role requires expertise in regulatory affairs and CMC strategy, particularly with China-specific regulations

Job Summary

  • The role involves independently managing new product registrations and life-cycle maintenance from a CMC perspective for Eli Lilly's portfolio.
  • Candidates must interpret China-specific regulations and communicate directly with the National Medical Products Administration (NMPA) on 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

Match Score: 85

Eli Lilly UK is seeking a Sr. Manager of Regulatory Affairs CMC, an individual contributor responsible for managing product registrations and lifecycle maintenance from a CMC perspective. The role requires expertise in regulatory affairs and CMC strategy, particularly with China-specific regulations.

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

  • FDA and EMA regulation knowledge
  • ADC, gene or cell therapy experience
  • Synthetic peptides and SiRNA experience
  • Strong English communication skills
  • Ability to shape regulatory environment

Key Requirements

  • Master degree in pharmaceutical or chemical sciences
  • At least 7 years experience in drug development
  • At least 3 years in global leading pharmaceutical company
  • Hands-on NDA/BLA project experience
  • Familiarity with China local regulations

Work Rights

Not specified

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