Sr. Manager Of Regulatory Affairs Cmc

Lilly

Not specified (assumed hybrid or flexible based on industry standards)
Master degree in pharmaceutical sciences
7+ years drug development experience
Full nda/bla project management
Lilly is seeking a Sr. Manager of Regulatory Affairs CMC to drive new product registrations and lifecycle maintenance from a CMC perspective. The role requires extensive experience in regulatory affairs within a global pharmaceutical company, with a focus on China-specific regulations

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 possess deep technical knowledge of CMC drug development science, analytical techniques, and manufacturing quality compliance systems.
  • The position requires actively shaping the regulatory environment by participating in industry platforms and maintaining relationships with key stakeholders.

Matching Summary

Match Score: 85

Lilly is seeking a Sr. Manager of Regulatory Affairs CMC to drive new product registrations and lifecycle maintenance from a CMC perspective. The role requires extensive experience in regulatory affairs within a global pharmaceutical company, with a focus on China-specific regulations.

Skills & Requirements

Must-have

  • Master degree in pharmaceutical sciences
  • 7+ years drug development experience
  • Full NDA/BLA project management
  • China regulatory guidelines expertise
  • CMC dossier preparation skills

Nice-to-have

  • Experience with ADC or gene therapy
  • Knowledge of FDA and EMA regulations
  • Strong English communication skills
  • Innovative problem-solving mindset
  • Global cross-functional team collaboration

Key Requirements

  • Master degree required
  • At least 7 years experience
  • 3 years in global pharma company
  • Hands-on NDA/BLA submission experience
  • Familiarity with China HA regulations

Work Rights

Not specified

Tailored Resume

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