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Regulatory Affairs Manager (1293)Biotest Pharmaceuticals - Boca Raton, FLSupervises and participates in the planning, preparing and interpreting regulatory documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, as well as an information source regarding product and assay development questions. Ensures corporate policies and procedures comply with regulatory requirements.Provides accurate and timely regulatory guidance to the R&D, manufacturing, operations and quality staff while maintaining frequent contact with the Senior Director.Responsible for preparation, review, presentation, and evaluation of all FDA submissions to assure accuracy and completeness of submission documents including meeting/briefing packages/ and presentations to the FDA... See job listing >3 days ago from BioSpace - Save - Block - Flag - More Tools...
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