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 11 years for experience in coordinating submissions and teams. He has published more than 40 initial INDs and 10 major marketing applications as well as 100s 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.