Ingrid Markovic

Ingrid Markovic, Ph.D., currently serves as the Head of Global RA CMC Policy at Novartis GRA CMC where she directs global CMC regulatory policy efforts that significantly impact product development across Novartis' extensive portfolio. Previously she held several positions of increasing responsibility at the FDA, both at CBER and CDER. In her last role at CBER/FDA she led enterprise-level strategy for pharmaceutical quality, CMC policy, and stakeholder engagement across CGTs, Vaccine, and blood product portfolios. She advised CBER executive leadership on opportunities for CMC innovation, emerging trends & challenges, and risk mitigation strategies; including leading cross-agency modernization of post-approval CMC reporting categories for complex biologics. Internationally, she was CBER’s ICH Quality Caucus Lead, Regulatory Chair for ICH Q6, Rapporteur for the Q3E informal EWG, FDA Lead for M4Q, and co-lead for Q12, and QDG. Her academic background includes a Ph.D. from the University of Wisconsin-Madison and postdoctoral training at NIH.