Derek Smith is the Director of the Division of Inspectional Assessment and the Acting Associate Director for Regulatory Affairs in the Office of Process and Facilities where he oversees the assessment of the manufacturing process and facilities for biologics and small molecule drug applications with a focus on the integration of application assessment and inspection findings and data reliability assessments. He also serves as the co-chair for the New Inspection Protocol Project (NIPP) initiative for pre-approval inspections and is a member of the Knowledge-aided Assessment and Structured Application (KASA) initiative steering committee. He holds a Ph.D in Chemical and Biochemical Engineering from University of Maryland, Baltimore County.