Director Regulatory Affairs
- Regulatory affairs (France)
- Promotional material review (medicinal products, medical devices)
- Early-access programs (ATU) assistance
Marie is a pharmacist and completed her Pharmaceutical education at the University of Grenoble, France (Thesis on Compassionate Use in Europe and France). She also obtained a Master Degree in European regulation of health products at the University of Lille and a Master Degree in Assessment and negotiation of health products at the University Paris V.
Marie has more than 15 years of experience in pharmaceutical industry, especially in the fields of market access and regulatory affairs (France, Europe).
Prior to joining BlueReg Pharma Consulting, Marie was at Pfizer France as Regulatory Affairs Manager for a number of products in areas such as oncology, anti-infectives and HIV. She was in charge of managing the local registration for products registered through centralized, MRP, DCP and national procedures, notably in charge of new Marketing Authorisation registration, and submission and following of pharmaceutical and clinical variations. She was also participating to development program for new drugs, notably through management of Clinical Trial Application (CTA) and Temporary Authorisation for Use (ATU) applications. Marie also participated to other activities such as Minimisation risk documents development, SOP management and had an experience in advertising control.
Prior roles at Pfizer included Pricing and Reimbursement Manager at Pharmacia France, where she has gained practical and valuable experience in Economic Affairs, for preparation and coordination of applications for registration on reimbursed medicines lists and management of prices.