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Senior Manager, Global Regulatory Sciences - CMC
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Full-time
- Position Summary / ObjectiveThe Senior Manager, GRS-CMC is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); &/or post-approval submissions.
- In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
- Position ResponsibilitiesSupport project teams (e.g. TPT / CMC, GRT, TTT, MLT, GO Team, etc.)
- Provide strategic CMC regulatory expertise for development project teamsProvide strategic input to development & GO teams to mitigate drug supply issues.
- Participate in product fact finding meetingsInterface with the US FDA for CMC submissions and CMC-related issues (either with the USL or directly)Communicate with project teams; in particular with regards to technical issues that may impact regulatory submissions, strategy, or success.
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