Senior Director, Global Regulatory Affairs, Devices & Digital Therapeutics, AstraZeneca. Tim joined AstraZeneca in 2007 to lead a team responsible for developing delivery devices for AZ’s new drug portfolio. This encompassed all dosage forms and had a significant focus on inhalation and injection devices.
Tim’s current role is to lead the Devices & Digital Therapeutics group within AstraZeneca Global Regulatory Affairs. The group is responsible for developing and implementing regulatory strategies and processes for both new and existing medical devices and combination products. This encompasses conventional pharmaceuticals, biologics and AZ’s increasing levels of activity in Digital Therapeutics.
Tim is the chair of the EFPIA Medical Devices Regulatory Working Group, as well as an active member of a number of other groups and associations including the Combination Products Coalition and IPAC-RS.
Before joining AstraZeneca, Tim led the Regulatory Affairs group at Valois Pharma (Part of the Aptar Group – a Manufacturer of Drug Delivery Devices) Tim was responsible for Valois’ regulatory strategy and provided technical & regulatory input to new product development.