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  1. Center for Drug Evaluation and Research | CDER

Office of Program and Regulatory Operations


  • Leads and manages operational infrastructure support for the entire Office of Compliance (OC) relating to project management, executive communications, workforce development, and drug registration and listing.
  • Designs and develops internal procedures and processes to support work quality, and oversight of implementation, monitoring, and continual improvement of the quality system.
  • Coordinates cross-functional projects led by CDER OC and involving other agency components to ensure appropriate teaming environments are developed and timelines and deliverables are met.
  • Assigns, tracks, and ensures timely resolution of all executive communications for the office.
  • Designs, develops, and implements workforce development programs to continually develop staff competencies and enhance job performance.
  • Manages drug registration and listing database and policy issues.
 
This Office consists of 3 Staffs: