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AstraZeneca is seeking an International CMC Regulatory Affairs Manager I to oversee the preparation and delivery of Chemistry, Manufacturing, and Control documentation for regulatory submissions. The ideal candidate will have extensive experience in the biopharmaceutical industry, strong project management skills, and a commitment to compliance with international regulations.
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Job Summary
In this role, 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 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: 75
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AstraZeneca is seeking an International CMC Regulatory Affairs Manager I to oversee the preparation and delivery of Chemistry, Manufacturing, and Control documentation for regulatory submissions. The ideal candidate will have extensive experience in the biopharmaceutical industry, strong project management skills, and a commitment to compliance with international regulations.
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Skills & Requirements
Must-have
CMC documentation management
International CMC regulatory submissions
Regulatory strategy
Stakeholder communication
GxP principles application
Nice-to-have
Bold questions
Modern tools adoption
Knowledge sharing
Lean capabilities
Key Requirements
University degree in science or technical field
Minimum 8 years relevant experience
Breadth of knowledge manufacturing, project, technical, regulatory management