Ursula Busse, PhD, MBA Novartis

Ursula is currently the Global Head of Quality Intelligence and External Affairs at Novartis. She drives the Novartis external engagement strategy in quality, technical and regulatory topics and leads global GxP regulatory intelligence.  Prior to her current role, Ursula held leadership roles in CMC Regulatory Affairs for biologics and in Biopharmaceutical Operations. Before joining Novartis in 2006, she worked for startup biotechnology companies in Canada for 10 years, in R&D, Quality Assurance and CMC Regulatory Affairs.  Ursula has been a long time member and volunteer of PDA. She received several PDA awards and served on PDA’s Board of Directors from 2012 to 2017. She is actively involved in a number of PDA committees and initiatives such as PDA PAC iAM, the PDA task force for post-approval changes. Ursula holds a Master’s degree in Biology from Tübingen University (Germany) and a PhD in Cellular and Molecular Biology from Laval University (Québec, Canada), coupled with an MBA she earned with honors.