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Regulatory Affairs Project Manager
We are currently searching for a senior-level Regulatory Sciences Project Manager; responsibilities include: Formulate and execute regulatory strategy, author submissions, and provide support across multiple therapeutic areas. Coordinate with US and international clients to provide regulatory strategy, guidance, and submission support. Plan, write and prepare documents for submission to FDA and international Health Authorities supporting clients’ investigational and marketing applications. Author and compile regulatory documents to support INDs, NDAs, BLAs, ANDAs and DMFs. Support al


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