Kathrin Schalper has more than 20 years of experience in Regulatory Affairs and Drug Development. Her development experience covers small molecules, therapeutic biologics (including gene therapy) and combination products through all stages from Preclinical to Commercial.
Prior to joining Halloran, Kathrin led the North America Regulatory Affairs team at Accenture, LLP and held various key roles in Regulatory Affairs, R&D Project Management and Pharmaceutical Development at Allergan, Novartis and Bayer.
Kathrin is a pharmacist by training and holds a Ph.D. in Pharmaceutical Sciences. In addition, she acquired the Regulatory Affairs Certification (RAC) for both the US and EU and she is a certified Project Management Professional (PMP). Kathrin teaches at the University of Southern California’s Department of Regulatory and Quality Sciences, serving as adjunct faculty for the Master Programs in Regulatory Sciences and Management of Drug Development. She is also a regular contributor to Regulatory Affairs Professional Society's (RAPS) Fundamentals of Regulatory Affairs series and other publications.