Regulatory Affairs Senior Consultant
- 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, specially 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 joins the STALLERGENES Laboratories, as International Regulatory Affairs Officer 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. Thus she was ensuring 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 products portfolio and thus reinforced her experience in the areas such as regulatory strategy for the development of a range, promotion review, « loi anti-cadeau » management, packagings 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. At the head of a team of pharmacists, she was responsible of 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 whole 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, on the one hand the organization and the management of all the regulatory activities of an pharmaceutical company (exploitant), and on the other hand the development of the portfolio of drug via the management of European procedures (DCP, MRP). In close collaboration with the other departments (Marketing and Bussiness 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 on the consulting and joins BLUE-REG PHARMA CONSULT in January 2017.