Mes compétences :
Affaires réglementaires
International
Pharmacie
Entreprises
GENETHON
- Regulatory Affairs Officer
Ivry2010 - maintenantEuropean regulatory processes related to advanced therapies and orphan drugs (Annual reports for orphan products designated for both the US and EU)
Clinical trial dossier submissions in Europe (Phase I/II for Gene Therapy Medicinal Products)
Genetically Modified Organism dossier submissions in national procedure
Regulatory Team Member in R&D Project Teams (Quality, non-clinical and clinical issues relating specifically to recombinat adeno-associated viral vectors and lentiviral vectors)
PIERRE FABRE MEDICAMENT
- Regulatory Affairs Officer
Castres2008 - maintenantRegulatory Project Manager within the Pierre Fabre Médicament laboratories (Boulogne, 92, France) in the International Department of Regulatory Affairs (18 months):
- Preparation and submission of standard regulatory documents (Application for Marketing Authorisations - Renewal of Marketing Authorisations -Variation to Marketing Authorisations dossiers), France EU and International.
- Preparation and submission of standard clinical trial documents (CTA)
- Participation as the Regulatory Team Member in R&D Project Teams for the development of new medicinal product (definition of regulatory development and registration strategies).
