Speakers

Gregory Seitz is currently Head of U.S. Regulatory Affairs – Generics at Sandoz, where he leads regulatory strategy for generic pharmaceuticals and oversees teams responsible for CMC, labeling, advertising and promotional review and regulatory operations. With more than 25 years of experience in the pharmaceutical industry, he has successfully built and led U.S. regulatory affairs organizations, guided complex FDA interactions across ANDA, 505(b)(2), and post-approval pathways, and supported the development and lifecycle management of a broad range of products and dosage forms. Greg is recognized for his expertise in regulatory strategy, FDA engagement, team leadership, and advancing innovative approaches that support patient access while maintaining product quality and compliance.  He holds a Master of Science in Regulatory Affairs from Temple University and a Bachelor of Science in Biology from Monmouth University.