Paul Z. Balcer

Paul Z. Balcer U.S. FDA Program Manager, OMQ, OC, CDER

Paul Z. Balcer joined FDA in 2003 as a consumer safety officer in CDER’s Office of New Drugs, Division of Anesthesia, Analgesia and Rheumatology Products (DAARP), where he served as a regulatory health project manager responsible for the management of IND and NDAs, and as a co-leader of project teams responsible for drug review activities. In 2007, Paul moved to CDER’s Office of Compliance where he was a special assistant to the director of the Division of Manufacturing and Product Quality (DMPQ), responsible for special projects/assignments, assisting the director in coordinating and managing daily operations for the division. He was an ORA investigator before joining the Office of Training, Education and Development (OTED), as a training officer, managing and developing pharmaceutical training courses for investigators and compliance officers. In 2019, Paul joined CDER’s Office of Manufacturing Quality, as program manager and a training lead, and with senior management, is responsible for leading and managing OMQ’s CGMP and technical training for OMQ staff. He is currently part of the PIC/S QRM Aide Memoire working group, responsible for revising the Aide Memoire to ICH Q9, QRM. Paul holds a Bachelor of Arts degree in Biology from George Mason University.