Regulatory Affairs Director
- Promotion review
- Promotion charter
- “Loi anti-cadeau"
- Transparency (sunshine act)
- CMC (module 3)
- Packaging review
Sophie has sixteen years of experience in the pharmaceutical industry, specifically in the France/Europe Regulatory Affairs field.
She began her career in 2000 at Laboratoires ROCHE as a Pharmacist at the Injectable Drug Production site in Fontenay-sous-Bois (94). For 2 years, she gained practical experience in the qualification / validation of equipment and manufacturing processes.
Sophie then joined the STALLERGENES Laboratories, as International Regulatory Affairs Officer working on a range of allergy products. She was in charge of local registration activities, particularly in the Eastern European zone, for medicines under national procedure. She provided oversight for the writing, submission and follow-up of applications for marketing authorization, clinical and pharmaceuticals variations.
In 2004, Sophie joined the NESTLE group within the NESTLE CLINICAL NUTRITION (NCN) pharmaceutical unit as Regulatory Affairs Manager for the product portfolio comprising Dietary Foods for Special Medical Purposes (FSMP), foods supplements and a Pharmaceutical specialty (RENUTRYL). She was in charge of the regulatory management of this product portfolio and thus reinforced her experience in regulatory strategy for the development of a product range, promotional review, « loi anti-cadeau » management, packaging and regulatory intelligence.
After 5 years at NCN, Sophie joined the MAYOLY SPINDLER Laboratory in early 2010 as Regulatory Affairs Manager in the France / Europe area. As the head of a team of pharmacists, she was responsible for the registration/maintenance of the entire portfolio of products of the Laboratory for France and Europe. She also oversaw, in partnership with the Head Pharmacist, the entire regulatory activities specific to France, including control of the promotion, certification of the Medical Visit, management of the law against gifts / transparency of the links, compliance and coordination with the different Authorities (ANSM, DGCCRF …).
During these 7 years, she acquired a solid expertise in firstly-the organization and the management of all the regulatory activities of a pharmaceutical company (exploitant) and secondly the development of the drug portfolio via the management of European procedures (DCP, MRP). In close collaboration with the other departments (Marketing and Business Development), she and her team have enabled the development of new ranges of food supplements and medical devices that have allowed the Laboratory to continue its growth. These experiences allowed Sophie to develop her skills in terms of project management, teamwork and information sharing. After 15 years of experience in the pharmaceutical industry, Sophie focuses her career in consulting and joined BlueReg in January 2017.