As Practice Leader for Actalent’s Clinical, Medical & Regulatory program, Gonzalo is a seasoned professional with more than 18 years’ experience in clinical, medical and regulatory affairs. He has worked with eight novel/innovative drugs/biologics, 50+ generic drugs and many medical devices and combination products for global product development and commercialization. He has broad therapeutic area experience and has participated in multiple regulatory compliance and notified body audits.
Gonzalo is currently responsible for overseeing and developing clinical, medical and regulatory services for Actalent Sciences, ensuring exceptional program operations to ensure high quality data and timeliness of clinical trials, evidence generation strategies and KOL development. He manages internal and external multi-disciplinary teams to ensure on-time and on-budget projects. Gonzalo completed his degree at the University of Toronto. He is a member of the Project Management Institute and The Society of Clinical Research Associates Inc.