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Sr Manager Regulatory CMC
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- The Senior Manager, Regulatory Affairs CMC, is responsible for providing regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders.
- This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide strategic and operational management of preparation and maintenance of CMC regulatory filings to support on going clinical activities as well as marketing applications.
- Develop regulatory CMC strategies and manage CMC regulatory filings in US and ex-US clinical and marketing applications.
- Escalate issues that affect regulatory compliance, promptly to CMC RA Management
- Experience in preparation of CMC sections for regulatory submissions (IND, IMPD, BLA, MA,A Amendments, Supplements etc)
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