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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

NEW! NEW!
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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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Fred Hutchinson Cancer Center

Multiple Locations, Washington

University of Utah

Salt Lake City, Utah

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Senior Director Regulatory Affairs
Responsibilities: Actively participate in client meetings as a regulatory affairs Subject Matter Expert. Assess client programs and provide regulatory consultation, gap analysis and recommendations for regulatory strategies and path forward. Assess situations and provide strategic regulatory pre-marketing and post-marketing advice based on regulatory experience and past successes, and in compliance with the applicable regulations. Plan submission strategies and health authority communications to develop successful product development plans to fruition through successful applications and submission life cycle management. Serve as the client’s US Agent with the FDA for applications to CDER and CBER. Represent clien


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