Manager, Cmc

Pfizer

Beijing, China
On-site
Cmc product information maintenance
Regulatory submissions
China regulatory requirements
Pfizer is seeking a Manager for CMC in Beijing, China, to oversee regulatory strategies and submissions related to drug development and manufacturing. The ideal candidate should have substantial experience in regulatory affairs, particularly in CMC for biologic products and vaccines, and demonstrate strong communication skills in both Chinese and English

Job Summary

  • Collaborate with departmental and cross-functional colleagues to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks.
  • Delivery of high quality regulatory submissions and maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance.
  • Serve as a primary CMC representative on a core project(s) and provide CMC support for products at various stages including clinical trial application, NDA and post approval variations.

Matching Summary

Match Score: 85

Pfizer is seeking a Manager for CMC in Beijing, China, to oversee regulatory strategies and submissions related to drug development and manufacturing. The ideal candidate should have substantial experience in regulatory affairs, particularly in CMC for biologic products and vaccines, and demonstrate strong communication skills in both Chinese and English.

Skills & Requirements

Must-have

  • CMC product information maintenance
  • regulatory submissions
  • China regulatory requirements
  • written and oral communication in Chinese and English

Nice-to-have

  • scientific and regulatory integrity
  • cross-functional collaboration
  • risk mitigation strategies

Key Requirements

  • 5+ years of experience in the pharmaceutical industry
  • 2+ years pharmaceutical regulatory experience
  • BS, MS or PhD degree in biotechnology, chemistry, or related scientific disciplines
  • Understanding of China, US and EU regulatory requirements

Work Rights

Not specified

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