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AstraZeneca is seeking an experienced International CMC Regulatory Affairs Manager II to manage documentation and submissions for Chemistry, Manufacturing, and Control (CMC) related to medicinal products. The role requires strong project management skills and the ability to communicate effectively with stakeholders while ensuring compliance with international regulations.
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Job Summary
You will effectively 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 contribute and lead the regulatory CMC components of business-related projects.
Here, your CMC regulatory expertise unlocks the full potential of pioneering therapies for patients with urgent needs.
Matching Summary
Match Score: 75
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AstraZeneca is seeking an experienced International CMC Regulatory Affairs Manager II to manage documentation and submissions for Chemistry, Manufacturing, and Control (CMC) related to medicinal products. The role requires strong project management skills and the ability to communicate effectively with stakeholders while ensuring compliance with international regulations.
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Skills & Requirements
Must-have
CMC documentation management
International CMC regulatory submissions
Regulatory CMC components
Interactive communication with stakeholders
Application of international CMC regulations
GxP principles application
Nice-to-have
Bold thinking and inspiring medicines
Kindness alongside ambition
Asking bold questions
Sharing knowledge across network
Key Requirements
University degree in science or technical field
Minimum 10 years relevant experience
Breadth of manufacturing, project, technical management