Arlene Wolny is the Global Head of Regulatory Affairs at Kashiv Biosciences, where she is committed to bringing affordable, high-quality biosimilars to patients worldwide to support healthier lives.
She has extensive global regulatory experience and a strong track record of shaping regulatory pathways, navigating complex approval environments, enabling faster development timelines, and ensuring robust life cycle management for approved products.
Previously, Arlene held senior roles at Biocon Biologics, Sandoz, Novartis, and Roche, and has worked extensively internationally. She holds a Master of Business Administration from Columbia University, a PhD in Pharmacology from the University of Basel in Switzerland, and an MS in Veterinary Medicine from The Ohio State University.
