International Cmc Regulatory Affairs Manager Ii

AstraZeneca

Hybrid (minimum of three days per week in the office)
Cmc documentation management
International cmc regulatory submissions
Project management
AstraZeneca is seeking an experienced International CMC Regulatory Affairs Manager II to oversee the preparation and submission of Chemistry, Manufacturing, and Control (CMC) documentation for medicinal products. The ideal candidate will have a minimum of 10 years in the biopharmaceutical industry with a strong knowledge of regulatory requirements and project management skills

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: 85

AstraZeneca is seeking an experienced International CMC Regulatory Affairs Manager II to oversee the preparation and submission of Chemistry, Manufacturing, and Control (CMC) documentation for medicinal products. The ideal candidate will have a minimum of 10 years in the biopharmaceutical industry with a strong knowledge of regulatory requirements and project management skills.

Skills & Requirements

Must-have

  • CMC documentation management
  • International CMC regulatory submissions
  • Project management
  • Stakeholder communication
  • International CMC regulations

Nice-to-have

  • Bold questions
  • Modern tools adoption
  • Knowledge sharing
  • Continuous improvement
  • Lean capabilities

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

Tailored Resume

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