Karen Ireland, MS, PMP, RAC-Drugs

Senior Regulatory Health Project Manager, Division of Regulatory Business Process Manager II, OPRO, OPQ, CDER

Karen Ireland serves as a Senior Regulatory Business Process Manager in OPQ’s Office of Programs and Regulatory Operations (OPRO). She has been in FDA with OPRO since 2017. She has a Bachelor of Science in Microbiology from University of California, San Diego and a Master of Science in Biotechnology (concentration in biodefense) from Johns Hopkins University. She also is certified in project management and regulatory affairs (drugs). She has experience supporting the quality review of abbreviated new drug applications and has represented OPRO in working groups for guidance and changes in the GDUFA III program.

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