International Cmc Regulatory Affairs Manager I

AstraZeneca

Hybrid (minimum of three days in the office)
7 years biopharmaceutical industry experience
University degree in science or technical field
Lead cmc content for marketing authorisation applications
AstraZeneca is seeking an International CMC Regulatory Affairs Manager I to manage the documentation for Chemistry, Manufacturing, and Control (CMC) for product ranges. The role involves coordinating international regulatory submissions, ensuring compliance with guidelines, and enhancing internal processes

Job Summary

  • This role manages the end-to-end delivery of Chemistry, Manufacturing and Control (CMC) documentation ensuring regulatory submissions meet business needs and patient expectations.
  • The position involves leading international CMC submission activities while maintaining strong communication with stakeholders to ensure timelines and risks are clearly understood.
  • AstraZeneca offers an inclusive environment where diverse perspectives are valued and people are trusted with real responsibility to drive impactful CMC submissions.

Matching Summary

Match Score: 85

AstraZeneca is seeking an International CMC Regulatory Affairs Manager I to manage the documentation for Chemistry, Manufacturing, and Control (CMC) for product ranges. The role involves coordinating international regulatory submissions, ensuring compliance with guidelines, and enhancing internal processes.

Skills & Requirements

Must-have

  • 7 years biopharmaceutical industry experience
  • University degree in science or technical field
  • Lead CMC content for marketing authorisation applications

Nice-to-have

  • Lean capabilities for process optimisation
  • Strong stakeholder and project management skills
  • Ability to shape internal guidance and policy

Key Requirements

  • Minimum 7 years relevant experience from biopharmaceutical industry
  • University degree in pharmacy, biology, chemistry or biological science
  • Breadth of knowledge in manufacturing and regulatory management

Work Rights

Not specified

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