FDAAA Leadership

Charles P. Hoiberg, Ph.D.

Charles P. Hoiberg, Ph.D.

Chuck Hoiberg served 25 years in the US FDA, most recently as Deputy Director of the Office of New Drug Chemistry/OPS in the Center for Drug Evaluation and Research (CDER). Additional duties included being the CDER International Conference on Harmonization (ICH) Quality Coordinator and the Quality Topic Lead for several ICH Quality Guidances and as the Chair of the FDA Regulatory Review Scientist GS14/15 Peer Review Committee. Before joining the Agency, he worked over eight years at Sterling Drug Inc. in R&D. On retirement from the FDA in 2003, he joined Pfizer Inc. as an Executive Director in Global Regulatory Chemistry Manufacturing and Controls. Currently, Hoiberg is also serving as the PhRMA representative to the ICH Quality eCTD Work Group. He has been very active in the International Society of Pharmaceutical Engineers (ISPE), most recently as the Chair of the ISPE International Board of Directors. He received a B.S. degree in Chemistry from the College of William and Mary and a Ph.D. degree in Biochemistry (Chemistry minor) from the Pennsylvania State University.