What
Where
10 miles
£
£

Regulatory CMC Associate Manager

East

40.00-55.00

Contract

Defining global CMC regulatory strategy and decisions for development

  • projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product life cycle, to project teams and appropriate management levels within and outside of Reg CMC.Influencing and negotiating within cross-functional teams to ensure quality submission planning and decision-making.Single point of contact with other line functions.Review CMC regulatory documentation to ensure strategic direction and regulatory compliance are met.Collecting documentation from other line functions to support submission preparation.

Posted 55 days ago

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