Executive Director, Global Regulatory Affairs – Head of Devices, Digital and Combination Products
Takeda
Cambridge, Massachusetts
Gretchen Vandal is the Head of Devices, Digital and Combination Products in Global Regulatory Affairs at Takeda. She has over 20 years of experience in the biopharma industry, supporting both drugs and devices. Her device regulatory expertise is in the area of digital technologies, including medical device software, clinical trial technology and drug development tools, digital biomarkers, and diagnostic algorithms. Prior to joining Takeda, Gretchen led the Global Regulatory Affairs Digital Health and Software Medical Devices team at Sanofi. Prior to that, she was in Global Regulatory Affairs at Biogen where she worked on combination products, SaMD, clinical trial technology, and companion diagnostics. She also spent several years at Amgen, where she held roles in both Quality and Global Regulatory Affairs. Gretchen holds a BS in Microbiology from the University of Rhode Island and a MS in Regulatory Affairs and a MBA, both from Northeastern University.
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Tuesday, October 18, 2022
9:00 AM – 10:00 AM ET