Roles of Regulatory Project Managers in the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research

Abstract

The 1992 Prescription Drug User Fee Act (PDUFA) mandate to implement project management within the Center for Drug Evaluation and Research’s new drug review process was clearly the springboard for the evolution of the regulatory project manager position. This role represents a challenging melding of two traditionally separate and fundamentally different functions: regulatory affairs and project management. The creation of this “hybrid” position was initially accomplished within the center by expanding the former consumer safety officer role within the Office of Review Management, an historically coordinator-type position with strong regulatory focus, to include that of project management principles. Regulatory project managers play key roles as coleaders of the review team, managers of the review process, regulatory managers, central communication points, and effectors of the center’s matrix functionality.