Head, Global Regulatory Affairs – (CoE)
AbbVie
James Wabby is an internationally recognized regulatory affairs leader with over 22 years of experience in complex product development. At AbbVie, he oversees global regulatory strategies across emerging technologies, drug-device combination products, and medical devices. He regularly advises AbbVie's therapeutic franchises on CMC dossier development, device delivery platforms, EU MDR/IVDR compliance, CE marking, ISO 13485/MDSAP, 21 CFR Part 3 and 4 for combination products, and human factors engineering.
James holds a BSc in Biology and an MHMS in Health Law & Policy from Duquesne University. He earned a Health Law and Life Science Regulatory Compliance certificate from Seton Hall University Law School, and completed RAPS Executive Development training at Northwestern’s Kellogg School
He is an Adjunct Assistant Professor at USC’s School of Pharmacy (Regulatory & Quality Sciences), Chair of the DIA Combination Products Committee, and actively chairs and moderates international regulatory symposia .
He’s also a member of ISPE, RAPS, DIA, ISPE, AAMI, AHLA, and ASQ workgroups.
Engineering Safety and Effectiveness for Regulatory Excellence in Drug-Device Combination Products
Thursday, October 9, 2025
1:00 PM - 2:00 PM EST