International Cmc Regulatory Affairs Manager Ii

AstraZeneca

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Cmc regulatory submissions
International cmc regulations
Project management
** AstraZeneca is seeking an International CMC Regulatory Affairs Manager II to oversee the production and submission of Chemistry, Manufacturing, and Control (CMC) documentation for medicinal products. The role requires extensive experience in regulatory affairs within the biopharmaceutical industry, emphasizing project management and stakeholder communication to ensure compliance with international regulations. **

Job Summary

  • Manage the timely preparation and delivery of CMC contributions to regulatory submissions throughout marketing authorisation applications and 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 submission of Chemistry, Manufacturing, and Control (CMC) documentation for medicinal products. The role requires extensive experience in regulatory affairs within the biopharmaceutical industry, emphasizing project management and stakeholder communication to ensure compliance with international regulations. **

Skills & Requirements

Must-have

  • CMC regulatory submissions
  • international CMC regulations
  • project management
  • stakeholder communication
  • GxP principles

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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