Kathrin Schalper

Kathrin Schalper, PhD, is a Regulatory Affairs executive with 20+ years of experience spanning a multitude of settings (blue chip pharma, emerging biopharma, consulting) across all phases of drug development and global lifecycle management in a wide range of therapeutic areas. She has extensive experience in interacting/negotiating with the FDA, EMA, Health Canada and national European agencies. Her leadership expertise covers both line management and matrix project environments. She is recognized as an expert in the areas of Global Regulatory Strategy, Drug Development and Project Management. She has held teaching and author assignments with the University of Southern California (USC) and the Regulatory Affairs Professional Society (RAPS).