International Cmc Regulatory Affairs Manager Ii

AstraZeneca

**
Cmc documentation management
International cmc regulatory submissions
Regulatory cmc project management
** AstraZeneca is seeking an International CMC Regulatory Affairs Manager II to oversee the production and management of Chemistry, Manufacturing, and Control (CMC) documentation for regulatory submissions. The ideal candidate will have significant experience in the biopharmaceutical industry, strong project management skills, and a deep understanding of regulatory processes. **

Job Summary

  • Manage the timely preparation and delivery of CMC contributions to regulatory submissions throughout marketing authorisation applications and all post approval activities.
  • Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
  • Join us in our unique and ambitious world where your CMC regulatory expertise unlocks the full potential of pioneering therapies for patients with urgent needs.

Matching Summary

Match Score: 75

** AstraZeneca is seeking an International CMC Regulatory Affairs Manager II to oversee the production and management of Chemistry, Manufacturing, and Control (CMC) documentation for regulatory submissions. The ideal candidate will have significant experience in the biopharmaceutical industry, strong project management skills, and a deep understanding of regulatory processes. **

Skills & Requirements

Must-have

  • CMC documentation management
  • International CMC regulatory submissions
  • Regulatory CMC project management
  • Stakeholder communication
  • Application of international CMC regulations

Nice-to-have

  • Drug development process knowledge
  • Lean capabilities
  • Bold thinking
  • Modern tools adoption

Key Requirements

  • University degree in science or technical field
  • Minimum 10 years relevant experience
  • Breadth of knowledge manufacturing, project, technical, regulatory management
  • IT Skills
  • Stakeholder & Project management
  • Regulatory knowledge

Work Rights

Not specified

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