Associate Director, Regulatory Affairs
- European procedures
- Middle East countries
- Life cycle management
Post-graduate diploma in Technology and Biochemical Engineering Projects – Bourgogne University – 2003
Master’s Degree in Biochemistry (Microbiology option) – UFR of Technical Sciences Tours – 2002
Anne-Valérie has extensive experience in Global Regulatory Affairs gained through many positions in the pharmaceutical industry over the past 14 years. She has expertise in a wide range of regulatory activities including registration, CMC writing and lifecycle management of different type of products (tablets, capsules, injectable, topical, …).
Prior to joining Blue Reg Europe, Anne-Valérie was Regulatory Affairs Area Support Manager at Galderma R&D (2014-2018) for EMEA countries (which includes European countries, Russia, CIS, MENA, South Africa, Pacific and Switzerland). In this role she was responsible of the registration and lifecycle management of drugs for countries listed above and she also worked as Middle East coordinator (management of site and drug list registration, regulatory requirements, …).
These experiences enabled her to extend and strengthen her skills in pharmaceutical development (Quality modules writing, file audit (CMC) and international registrations (national, European procedures (MRP/DCP/CP), emerging markets) of drug products acquired during her previous roles within Teva Generics, Mylan, Sanofi Pasteur and AGUETTANT Laboratories.
In May 2018, Anne-Valérie moved to consultancy and joined Blue Reg Europe.