Global Head, Regulatory Affairs, AbbVie, Inc.
Global Head, Regulatory Affairs – (CoE)
(Emerging Technologies, Combination Products and Medical Devices)
James P. Wabby, MHMS, is Global Head, Regulatory Affairs–(CoE) (Emerging Technologies, Combination Products, and Medical Devices) at AbbVie, Inc. He has over 20 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP-regulated environment pertaining to medical device, technology medicinal delivery platforms, complex generics, companion diagnostics, digital medicine, and combination product areas. James is also an Adjunct Assistant Professor at USC School of Pharmacy–Regulatory and Quality Sciences and an international speaker, chair, and keynote at various symposia, Chairman of the DIA Combination Products Committee, and a moderator for various global regulatory panel discussions. He has a BSc in biology and MHMS in health law and policy from Duquesne University. He has been an ISPE member since 2020.
Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system arena and regulatory affairs regarding:
• CMC Global Dossiers and Global Device Regulatory Strategy Registrations
• EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
• Digital Medicine
• 21 CFR Part 3 and Part 4 - Combination Products
• CE Marking
• ISO 13485:2016/MDSAP including Regulatory Inspection Management and production controls
• Product Development – Design Controls/Risk Management/Human Factors Engineering
• Acquisitions/Divestitures, Import/Export – U.S. Agent
• Health-Care Related Laws and International Regulations
2000 – BSc., Biology, Duquesne University
2002 – MHMS, Health Law and Policy, Duquesne University
2011 - Certificate, Health Law and Life Science Regulatory Compliance, Seton Hall University Law School
2022 – Certificate, RAPS Executive Development Program, Northwestern University - Kellogg School of Management
Member of various regulatory work groups including DIA, RAPS, RAPS/AFDO, AAMI, ISPE, OCRA, SDRAN, ASQ Orange Empire Section, and ASQ San Diego.