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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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University of Texas Medical Branch at Galveston

Galveston, Texas

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CHRISTUS Health

New Braunfels, Texas

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Fred Hutchinson Cancer Center

Seattle, Washington

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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

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Kindred Hospitals

San Leandro, California

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

Chicago, Illinois

Kaiser Permanente

Pasadena, California

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ScionHealth

Louisville, Kentucky

Kansas State University

Manhattan, Kansas

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Kindred Hospitals

Northlake, Illinois

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CHRISTUS Health

San Antonio, Texas

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Surgenex

Scottsdale, Arizona

Michigan State University

East Lansing, Michigan

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Regulatory Affairs Coordinator
Objective The Regulatory Affairs Coordinator will provide various regulatory and administrative support for the clinical research programs.  The position will assist with regulatory document preparation, editing of regulatory and clinical documents and provide general administrative support to the Clinical and Manufacturing teams.    Regulatory Support Duties Assists in preparation and review of Clinical Trial Protocols, Study Reports, Investigator’s Brochures, etc. Assists in preparation of non-clinical (M 2.4, 2.6), (M 4) and clinical (M 2.5, 2.7) parts of the CTD dossier for INDs in the USA with subsequent submission of the regulatory documents to the eCTD publisher. Assists in the preparation of clinical


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