Fresnes
Since Feb 2005  Fresenius-Kabi - Paris (France) – EAMA Regulatory Affairs Coordinator: responsible for Europe, America, Middle East and Africa of the global strategy for the registration of Medicinal products, enteral nutrition and Medical devices, audit, coaching and set up of national RA organisations, hiring of RA professionals, follow-up of RA budgets for the region, chairman or member of various corporate steering committees such as RA, quality, etc…, main contact for corporate board members and national general managers.
1997 - 2005  Baxter - Maurepas (France) - European Regulatory Affairs Manager: responsible for the registration of products through European MRP with France, UK and Sweden as RMS, set up of global RA strategies for drug development, leading role for projects in a complex matrix environment (collaboration with business, logistic, manufacturing, R&D counterparts), coordination of various European regulatory activities, contact with Medical Agencies, management of a team of 2 regulatory affairs professionals, relationships with suppliers, technical support for RA colleagues on various subjects: sterility, impurities, BSE, international issues, etc…
1994 - 1997  Institut de Recherche Biologique Yves Ponroy - Les Clayes-sous-Bois (France) - Head of Regulatory Affairs: creation of a drug establishment, development of new drugs and preparation of their marketing authorisation applications in France and abroad, buying of licensed products, project management, sub-contractors’ follow-up, set up of quality assurance procedures, development of food supplements.
1992 - 1994  Schering-Plough - Dardilly (France) - Research scientist: development of a surgical cement powder, control of raw materials and finished products.
1991 - 1992  Compulsory military period at the « Élément Militaire Médical d’Intervention Rapide » - Bron (France) - Lieutenant: Pharmacist in charge of stock control of the Mobile Hospital Unit.
1991  SmithKline-Beecham - Epsom (United Kingdom) - Trainee (6 month training period at the Great-Burgh research centre): process validations.
1991  Ravouna Pharmacy - Charvieu (France) - Assistant pharmacist
2 months.
1989 - 1990  Institut de Pharmacie Industrielle de Lyon - Traineeship (1 year): Microencapsulation by coacervation: optimisation of a process.
Study of the Cellulose Acetate Trimellitate as coating agent.
1987 -1990  Lyon Hospitals - Trainee in various departments of Pharmacy, Biochemistry, Haematology and Toxicology.
1986  Barriol Pharmacy - Pont de Cheruy (France) - Summer job
1 month.
Mes compétences :
Affaires réglementaires
Food
Licensing
Médical
Medical devices
Regulatory Affairs
Pas de formation renseignée
