Hays Resource Management - Astrazeneca
Macclesfield, Cheshire, United Kingdom
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Regulatory CMC Associate
Contract duration: 12 months
Remuneration: Competitive hourly rate
Regulatory CMC Associate are required to produce and support the production of Chemistry, Manufacturing and Control (CMC) documentation for designated commercial products at various stages of product life cycle, in the required format and to the agreed timetable.
The Regulatory CMC Associate is responsible for:
Providing CMC regulatory and compliance advice on regulatory post-approval submissions
Working cooperatively with stakeholders across CMC Regulatory Compliance, Global Regulatory Affairs and Operations
Supporting the timely submission of post approval CMC documentation
Coordinating assembly and/or generate documentation of submission-ready components to support life cycle submissions
Review and approval of regulatory CMC documents on behalf of CMC Regulatory Compliance
Support cross-functional approval for delivery of the documentation to Global Regulatory Affairs for worldwide use in regulatory submissions
Notify manufacturing sites of health authority approvals
Updating all relevant electronic systems to be consistent with regulatory submissions and commitments.
Graduate in a scientific discipline eg chemistry, pharmacy or biological science
Basic knowledge of the drug development process and regulatory submissions
Experience in Pharmaceutical Production, Regulatory Affairs, Quality Assurance, R&D
Understanding of current regulatory CMC requirements
This position would be suitable for a recent graduate