Manager, Cmc

Pfizer

China us eu regulatory requirements knowledge
Biologic products and vaccines background
Chinese and english written oral communication
Collaborate with cross-functional colleagues to leverage technical and regulatory knowledge for global drug development projects

Job Summary

  • Collaborate with cross-functional colleagues to leverage technical and regulatory knowledge for global drug development projects.
  • Ensure high quality CMC submissions in compliance with China regulations while managing regulatory issues and timelines.
  • Serve as a primary CMC representative providing support for products at clinical trial, NDA, and post-approval stages.

Matching Summary

Collaborate with cross-functional colleagues to leverage technical and regulatory knowledge for global drug development projects.

Skills & Requirements

Must-have

  • China US EU regulatory requirements knowledge
  • Biologic products and vaccines background
  • Chinese and English written oral communication

Nice-to-have

  • Documentum-based applications proficiency
  • Cross-functional strategic initiative contribution
  • GMP development and commercial activities knowledge

Key Requirements

  • BS MS or PhD in biotechnology chemistry or related field
  • 5+ years pharmaceutical industry experience
  • 2+ years pharmaceutical regulatory experience

Work Rights

Not specified

Tailored Resume

Cover Letter