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Description
JOB DESCRIPTION
Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives.
Lead global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions.
Develop global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead’s operations.
Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.
Lead the integration and implementation of CMC Team Leaders and CMC Strategies (Regulatory Scientists).
Lead development of regulatory strategies and solutions for com...