Consultant, Regulatory Affairs
Sophie is a pharmacist with 6 years of experience in Regulatory Affairs on EMEA region.
From 2010 to 2016, Sophie worked at the French affiliates of Alcon and Johnson & Johnson Santé Beauté France and at the head offices of Servier and Effik. Through these different experiences, she has developed skills in the registration of product licenses and their maintenance in Europe (preparation of dossiers, submission and follow-up of CMC and safety variations, renewal dossiers, periodic safety update reports) at both affiliate and corporate level.
In August 2016, Sophie joined Galderma as Global Regulatory Affairs Manager EMEA/Russia/CIS/Pacific. She strengthened her skills in the registration and life-cycle management within the European region and developed expertise in the coordination of registration activities worldwide. She also developed skills in validation of promotional materials for international congresses and global campaigns as well as the coordination of product information compliance project and in the management of CRO. In this position, she was appointed regulatory coordinator of the sub-region Europe & Switzerland for the EAME regulatory team.
In May 2018, Sophie moved to consultancy and joined BlueReg as Regulatory Affairs consultant where she continues her regulatory activities in the registration, in the life-cycle management and also in the development of pharmaceutical products.