International Cmc Regulatory Affairs Manager Ii

AstraZeneca

Hybrid (average minimum of three days in the office per week)
Cmc documentation management
International cmc regulatory submissions
Regulatory strategy
AstraZeneca is seeking an International CMC Regulatory Affairs Manager II, responsible for managing Chemistry, Manufacturing, and Control (CMC) documentation and international regulatory submissions for medicinal products. The role emphasizes project management, compliance with CMC regulations, and collaboration with stakeholders to ensure timely delivery of submission-ready materials

Job Summary

  • Manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs of both the AZ business and the customer.
  • You will project manage international CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle.
  • Here, 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 International CMC Regulatory Affairs Manager II, responsible for managing Chemistry, Manufacturing, and Control (CMC) documentation and international regulatory submissions for medicinal products. The role emphasizes project management, compliance with CMC regulations, and collaboration with stakeholders to ensure timely delivery of submission-ready materials.

Skills & Requirements

Must-have

  • CMC documentation management
  • International CMC regulatory submissions
  • Regulatory strategy
  • Project management
  • Stakeholder communication

Nice-to-have

  • Continuous improvement
  • Bold thinking
  • Kindness alongside ambition

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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