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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
United States - Nationwide
University of Texas Medical Branch at Galveston
Galveston, Texas
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois
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VP of Regulatory Affairs
The Vice President of Regulatory Affairs will be accountable for developing and executing the global regulatory strategy with expertise in neurosciences/CNS therapeutic area. This individual will have experience in leading project teams for the preparation of pre-IND, EOP2, pre-NDA, etc. briefing documents & meetings with the FDA. The VP of Regulatory Affairs will be accountable and responsible for IND and NDA documents and will lead a small team of regulatory affairs professionals. This individual will, with a high sense of urgency, develop regulatory strategy based on new or 505(b)(2) drug development principles, regulatory guidance documents, and by getting input from cross-functional team members. This individual will also be responsible for providing regulatory input to c
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