Senior Regulatory Affairs Consultant
Mélisa is a pharmacist and completed her Pharmaceutical education at the University of Strasbourg, France (2002). She also obtained a Master Degree in Regulatory Affairs Health Industry at the University of Paris XI (2003).
Mélisa has 10 years of experience in the pharmaceutical industry and within a health authorities, especially in the field of Regulatory Affairs (France).
She started her professional career in 2002 at AVENTIS FRANCE as Regulatory Affairs Manager where she has gained practical experience in registration and management of advertising control for Oncology and Gynecology products.
In 2004 Mélisa joined ROCHE PHARMA FRANCE as Registration Project Manager in charge of Hepatology and Rheumatology products. She was in charge of local registration activities for medical products registered under centralized procedure, MRP and national procedure, notably assuming submission and follow-up of MA requests, clinical and pharmaceutical variations, and clinical trials applications (CTA) and amendments.
Then Mélisa joined SCHERING-PLOUGH FRANCE as Regulatory Affairs Manager in charge of Allergy and Dermatology products. She was in charge of the regulatory management of this products portfolio and reinforced her expertise in the fields of registration, advertising control, clinical trials, packaging and regulatory survey.
After 5 years in the pharmaceutical industry, Mélisa joined ANSM (French Health Agency) in 2007 as an Advertising Assessor. She was in charge of Cardiology, Urology, Nephrology and Antifungal products. As a regulatory and scientific assessor, she gained a strong expertise in the field of the analysis of advertising material for physicians, of risk minimization plans and patients programs documents, through a tight collaboration with other departments of ANSM and external experts.
Through these experiences, Mélisa has developed her skills in terms of project management, team work and information share.
After 10 years of experience within the pharmaceutical industry and ANSM, Mélisa moved to consultancy and joined BLUE-REG PHARMA CONSULT in January 2015.