Senior Consultant Regulatory Affairs
Pharmacist Doctorate held in the University of Paris V, France (2001)
Master’s Degrees in Health products regulations within European Union from Lille University (2002), Clinical Trials Results Interpretation from Lyon 1 University (2009) and Pharmaceutical & Drug Safety from Paris V University (2010)
Virginie has a broad experience in Regulatory Affairs and Quality Assurance gained through several positions in the pharmaceutical industry over the past 17 years.
Virginie has been involved in various regulatory projects assisting SME to international companies as regulatory affairs project manager.
Previously, Virginie was Regulatory Affairs and Product Quality Assurance Manager at Mylan Medical in Paris.
She was in charge of the registration and the lifecycle management of drugs for France and International Trade Business (Maghreb and North of Africa) with National and European Procedures, the regulatory compliance of pharmaceutical dossier, the validation of promotional marketing and training materials, the approval of packaging items, the preparation of Transparency files and PSURs for local products.
In addition she managed quality assurance dealing with quality complaints management, Product Quality Reviews, CAPAs, creation and revision of regulatory and quality standard operating procedures and audits.
Prior to this, Virginie held Promotion and Drug Registration Manager positions particularly at Meda, Novartis and Sanofi-Aventis.