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Manager, Regulatory Affairs CMC
Our Regulatory Affairs team brings essential generic quality medicines to our hospital members in the United States by providing CMC Regulatory leadership and establishing Civica’s Regulatory Affairs systems and processes. The Manager, Regulatory Affairs CMC: Provides CMC regulatory support for development programs and marketed products. Develops product CMC regulatory strategy for essential generic medicines and obtains shortest time to approval by regulatory agencies. Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, and other regulatory filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met. Critically reviews documentation intended for sub


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