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Heather Guerin, PhD, PE (she/her/hers)

Global Program Regulatory Director
Novartis

Heather Guerin is currently Global Program Regulatory Director, Medical Devices, at Novartis. In her current role, Heather is involved in leading regulatory strategy for drug-device combination products for the delivery of drugs in a variety of therapeutic areas. Heather has a background in medical device and combination product regulatory affairs, having spent time developing global regulatory strategies and clinical and commercial submissions for the use of novel diagnostics in drug clinical trials in oncology and maternal-fetal medicine; for drug-device combination products for the delivery of biologics, small molecules, and cell and gene therapies in a variety of therapeutic areas including immunology, oncology, ophthalmology, and infectious disease; and for standalone medical devices for spinal and craniomaxillofacial applications. Heather holds a Ph.D. in Mechanical Engineering from the University of Pennsylvania and a B.S. in Mechanical Engineering from Villanova University. She is a registered Professional Engineer in the state of Pennsylvania.

Presentation(s):

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