Simon Leppard
About Simon Leppard
Simon Leppard is a Senior Fellow in Regulatory Affairs at Boston Scientific with extensive experience in regulatory submissions and interactions with major global regulatory authorities.
Current Role at Boston Scientific
Simon Leppard currently works as a Senior Fellow in Regulatory Affairs at Boston Scientific. He has been with the company in this capacity since 2021. His work involves high-level regulatory strategy and oversight, focusing on ensuring compliance with various regulatory requirements globally. He is based in the United Kingdom.
Past Experience at Boston Scientific
Before becoming a Senior Fellow, Simon Leppard served as the Director of Regulatory Affairs at Boston Scientific from 2019 to 2021. In this role, he managed regulatory submission and compliance activities in Camberley, Surrey. His expertise included strategic regulatory planning and interactions with major regulatory authorities.
Experience at BTG plc
Simon Leppard has a substantial history with BTG plc, where he held several key roles. From 2016 to 2019, he was the Director of Regulatory Affairs for IO Embolic Products. Prior to this, he was the Director of Regulatory Affairs for Interventional Vascular from 2013 to 2016 and Regulatory Affairs Manager CMC for Interventional Vascular from 2012 to 2013. Starting in 2011, he managed Regulatory Affairs for Interventional Oncology at Biocompatibles UK Ltd, part of the BTG Group.
Educational Background
Simon Leppard's educational background is extensive and specialized. He achieved his BA Hons in Natural Sciences (Chemistry) from the University of Oxford in 1990, followed by a dPhil in Organic Chemistry from the same institution in 1994. He then completed post-doctoral studies at Laboratoire de Chimie de Coordination in Toulouse, focusing on Chiral Oxidation, and at the University of Groningen, studying P450 oxidation mimics.
Expertise in Regulatory Affairs
Simon Leppard has over 8 years of direct regulatory experience in combination products and more than 7 years of experience working with partners in Asian territories for regulatory approvals. He has direct interaction experience with major regulatory authorities such as MHRA, AEMPS, BFARM, MEB, FDA, and Health Canada, and indirect interaction experience with authorities including SFDA, PMDA, ANVISA, TGA, TFDA, KFDA, and Cofepris. His specialties include regulatory submissions for Class IIb, III, and combination products, as well as obtaining orphan drug designations in the EU.