Manager, Cmc

Data Science Jobs

Beijing, China
On-site
Cmc regulatory knowledge
China regulations and guidelines
Written & oral communications in chinese and english
The job posting is for a Manager, CMC at Pfizer in Beijing, China, focusing on regulatory affairs related to drug development and manufacturing. The role involves collaboration across departments to ensure compliance with regulatory requirements, high-quality submissions, and effective project management

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.
  • 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.
  • Ensure high quality CMC submissions in compliance with China regulations and guidelines.

Matching Summary

Match Score: 85

The job posting is for a Manager, CMC at Pfizer in Beijing, China, focusing on regulatory affairs related to drug development and manufacturing. The role involves collaboration across departments to ensure compliance with regulatory requirements, high-quality submissions, and effective project management.

Skills & Requirements

Must-have

  • CMC regulatory knowledge
  • China regulations and guidelines
  • written & oral communications in Chinese and English

Nice-to-have

  • scientific & regulatory integrity
  • cross-functional and strategic initiatives
  • collaboration with global partners

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

Work Rights

Not specified

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