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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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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

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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

IEHP

RANCHO CUCAMONGA, California

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Senior Regulatory Affairs Specialist
Job Summary: The Sr. RA Specialist provides support for the regulatory department to ensure efficient and compliant business processes and environment. Partner across business functions assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for product registrations.   Essential Functions & Accountabilities: Leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems. Review and approve device labeling and marketing materials for compliance with applicable regulations. Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.


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