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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
United States - Nationwide
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University of Texas Medical Branch at Galveston
Galveston, Texas
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois
Fred Hutchinson Cancer Center
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Principal Specialist, Regulatory Affairs
The Principal Specialist is responsible for the development and implementation of complex global regulatory strategies for the Pharmaceutical GBU including; biosimilars, generics, 505(b)(2) and combination products. The person in this position will obtain and maintain marketing authorizations for US and EU (via CP, DCP, MRP, Worksharing, etc.) and will also provide oversight and support regulatory activities for Rest of World registration(s). Essential Duties and Responsibilities Initiate and develop complex regulatory project plans for New Product Development and Post-Market Variations Identify & prioritize key areas of regulatory risk Provide regulatory advice to project teams Respond to complex que
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