Julianne McCullough U.S. FDA

Julianne McCullough

Julianne McCullough U.S. FDA Senior Mutual Recognition Program Officer, OMPTO, ORA

My name is Julianne McCullough, and my career with FDA began in 2002 as a consumer safety officer in the Office of Regulatory Affairs (ORA) Philadelphia District Office, the lead office for all agency field activities, including inspections of drug product manufacturers, both foreign and domestic. Prior to joining ORA HQ in 2019, I served as expert in post market compliance & surveillance in the Office of Pharmaceutical Quality (OPQ)/Office of Quality Surveillance (OQS)/Inspection Assessment Branch (IAB) at the Center for Drug Evaluation and Research (CDER).I am currently serving as the senior Mutual Recognition Agreement Program Expert in ORA's Office of Pharmaceutical Quality Operations, Division of Pharmaceutical Quality Programs. In my office, I am responsible for leading and coordinating many of the day-to-day operational aspects of the MRA program, facilitating communication with our MRA partners and stakeholders, and serving as a point of contact for technical MRA program questions from within and outside the Agency.