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Applied Pharmaceutical Innovation Logo
Applied Pharmaceutical Innovation

Canada - Nationwide

Numab Therapeutics AG

Switzerland

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Promega Corporation

Madison, Wisconsin

Kriya Therapeutics

Morrisville, North Carolina

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Battelle Memorial Institute

Columbus,

US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS Logo
US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS

United States - Nationwide

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Baylor Scott & White Health

Remote,

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Baylor Scott & White Health

Dallas, Texas

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Kindred Hospitals

San Leandro, California

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CHRISTUS Health

New Braunfels, Texas

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University of Texas Medical Branch at Galveston

Galveston, Texas

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ECU Health North Hospital

Roanoke Rapids, North Carolina

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CHRISTUS Health

Shreveport, Louisiana

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Kindred Hospitals

Dover, New Jersey

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AdventHealth

Daytona Beach, Florida

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois

Kaiser Permanente

Pasadena, California

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ScionHealth

Louisville, Kentucky

Michigan State University

East Lansing, Michigan

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Surgenex

Scottsdale, Arizona

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Fred Hutchinson Cancer Center

Multiple Locations, Washington

University of Utah

Salt Lake City, Utah

IEHP

RANCHO CUCAMONGA, California

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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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