Daniel Smith brings over 20 years of experience to the Halloran Regulatory Operations team encompassing Regulatory Affairs, Medical Writing, Clinical Research and Regulatory Operations. Within the Regulatory Operations space he has over 14 years for experience in coordinating submissions and teams. He has been involved with more than 100 initial INDs, 10 major marketing applications, as well as 1000s of eCTD lifecycle and NeeS submissions. He has additional regulatory experience with elastomeric container closures and coordination/Authoring/Submission of DMFs for both Type III and Type V to FDA as well as Type II to Bureau of Pharmaceutical Sciences, Health Canada.
Prior to joining Halloran, Daniel was a Director of Medical Writing at Teva Pharmaceuticals where he was responsible for Operations, Systems, Inspection Readiness, Annual Reporting, and Clinical Document Publishing.
Bloomsburg University, Mass Communications (BA)
West Chester University, Cell & Molecular Biology (BS)
Temple University, Quality Assurance and Regulatory Affairs (MS)