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Parenteral Drug Association Connecting People, Science and Regulation ®

Ursula Busse, PhD, MBA

Ursula currently holds a global position as Head of GxP Regulations Coordination for Quality External Relations at Novartis. Her responsibilities include external relations activities and regulatory intelligence related to key quality activities. She joined Novartis in 2006 in CMC regulatory affairs for biologics, moved to Biopharmaceutical Operations as Head of Project Office, and took on to her current position in October 2013. Prior to joining Novartis, she worked for 10 years in small biotech companies in Canada, starting as a scientist and project manager, and moving to positions with increasing responsibility in Quality Assurance and CMC regulatory affairs.

Ursula has been a long time member and volunteer of PDA. She received the PDA Distinguished Service Award in 2010 for contributions to the success and strength of PDA, and joined PDA’s Board of Directors in 2012.

She holds a Master’s degree in Biology from Eberhard-Karls University Tübingen (Germany) and a PhD in Cellular and Molecular Biology from Laval University (Québec, Canada), coupled with an MBA she earned with honors.