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Principal Scientist - Global Regulatory Affairs - CMC
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- Regulatory Affairs is core to delivering our product pipeline via management of global submissions for both New Chemical Entities (NCE’s) & New Molecular Entities (NME’s) and global post approval change management for commercial products, thus ensuring reliable supply and continuous improvement.
- The purpose of the Principal Scientist- Global Regulatory Affairs-CMC role is to provide strategic, tactical and operational direction to expedite CMC development of Lilly’s portfolio and technical agenda by supporting global clinical trial, market registration submissions, and post-approval submissions.
- To accomplish this purpose, it is necessary for the Regulatory Scientist to develop collegial and mutually productive relationships and by a demonstrated ability to establish and/or to promote / refine key regulatory CMC positions and to effectively influence development, manufacturing, and GRA leadership on these positions.
- Will develop, plan and execute appropriate regulatory strategies and priorities through effective partnership with other departments such as TS/MS (process and technology transfer), manufacturing, quality control and quality assurance
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