Description: This position interacts with multiple departments, as appropriate, involved in regulatory submissions. The position, under supervision of the manager, makes FDA submissions, reviews requisite/critical documents and reports for completeness and suitability for submission. Specific Responsibilities Receive documents from various sources and review for completeness and suitability for submission to FDA. Request missing and/or illegible pages, arrange for translations as needed. Review regulatory documents to assure FDA requirements are met and are ready for submission. Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies.
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