Regulatory and Pharmaceutical Affairs Advisor
Doctor of Pharmacy
MSc Pharmaceutical biotechnology and advanced therapies
Caroline has acquired a solid and varied experience in different types of activities in regulatory affairs thanks to her 9 years of experience within different large laboratories – Parent company: Servier, Sanofi and LFB-Biomedicaments, then in subsidiary France – Exploitant: Novo Nordisk and MSD Vaccines and in CRO within Syneos Health.
She first started her career in clinical research during which she was entrusted with various projects in the framework of clinical studies at European level as well as at local level. This gave her the opportunity to specialise in projects related to Innovation.
Caroline then decided to focus her career on registration activities such as the management of registration procedures in Europe and France, their lifecycle management, and local specificities such as the updating of packaging items.
She has also coordinated projects related to the Exploitant Pharmaceutical Establishments such as the management of stock shortage declarations with the implementation of Shortage Management Plans and alternative solutions according to the new regulations. She also had the opportunity to manage a project to relocate an exploitant site with the management of the application for authorisation to open the new operating site with the transfer of the head office, and the filing of variations related to this change of address. All this experience gives her versatility in these activities within Atessia.
Caroline likes the diversity of the missions offered by the regulatory field and the collaboration within projects. She knows how to adapt and listen to everyone.