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Sanofi-aventis
- RSO Head
Paris
2010 - maintenant
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Sanofi pasteur
- Head Reg CMC Global Standards
Lyon
2009 - 2010
Management of a Global Team (height people located in Canada, France and the US).
Primary responsibilities:
- ensure development and implementation at Global level of common CMC Templates for vaccines (Module 3, 2.3...),
- ensure definition and implementation of Global CMC Processes and verify efficacy of new processes,
- coordinate the CMC training for expertise development and CMC knowledge,
- Reg CMC representative for development of Global transversal process and system,
- responsible for budgeting and reporting.
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Sanofi Pasteur
- Directeur Adjoint Compliance France
Lyon
2007 - 2009
Responsible for regulatory compliance of both French manufacturing sites.
Team management (four people).
- Management and accountable for regulatory compliance activities and processes for regulatory affairs department and in line with Global policies,
- coordinate activities in cooperation with US and Canadian compliance teams,
- regulatory affairs representative to industrial projects,
- management of regulatory assessment of the changes to ensure the compliance of the regulatory authorisations and the industrial practices,
- provide regulatory support to inspections,
- management of US and Canadian Annual Report for the French products,
- empowered to represent regulatory affairs and provide the global regulatory position in several committees such as change control board, deviation reports committee, post-approval commitements managements,
- responsible for budgeting and reporting.
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Novartis Consumer Health
- Senior Manager Regulatory Affairs
RUEIL MALMAISON
2005 - 2007
Senior Manager Regulatory Affairs - Derm category (Since Apr 2007)
Manager Regulatory Affairs - Derm category (Oct 2006-Mar 2007)
Responsible for Derm category
Europe and Rest of the World countries.
Team management (three people).
- Management of regulatory activities for Lamisil, Fenistil and Vectavir brands,
- responsible for budgeting and reporting,
- regulatory correspondent for projects team,
- management of registration strategies (European procedures),
- management of submission and follow-up for Marketing Authorisation application (national, MRP/DCP),
- preparation of Marketing Authorisation and Rx to OTC switch dossiers,
- preparation of Cosmetic dossiers.
Manager Regulatory Affairs - Analgesics category (Jun 2005-Sep 2006)
Europe and Rest of the World countries.
Team management (two people).
- Management of regulatory activities for systemic and topical analgesics of Voltaren brand,
- management of registration strategies (European procedures),
- management of submission and follow-up for Marketing Authorisation application (national, MRP/DCP),
- preparation of Marketing Authorisation and Rx to OTC switch dossiers,
- preparation of Food Supplement dossiers.
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Merck Génériques
- Responsable Affaires Réglementaires - Gamme injectable
2001 - 2005
Regulatory Affairs Manager - Business Unit for Injectable Products (Dec 2003-May 2005)
France and International (Japan, Canada, Europe, Rest of the World…)
Four people team management.
- Departmental organisation, preparation and follow up of budget,
- management of submission and follow-up for Marketing Authorisation application,
- preparation of Marketing Authorisation dossiers,
- validation of promotional documents, patient information leaflet and labeling,
- follow-up and advices for pharmaceutical development,
- management of registration strategies,
- audit of registration dossiers,
- writing and submission of variations,
- writing of the application files for the French Transparency Commission.
Regulatory Affairs Associate - Injectable Products (Mar 2001-Nov 2003)
France and International (Japan, Canada, Europe…)
- Management of part of the range of products,
- progressively, direct report management,
- management of submission and follow-up for Marketing Authorisation application,
- preparation of Marketing Authorisation dossiers,
- validation of promotional documents, patient information leaflet and labeling,
- follow-up and advices for pharmaceutical development,
- management of registration strategies,
- audit of registration dossiers,
- writing and submission of variations,
- writing of the application files for the French Transparency Commission.
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Spécialités Septodont
- Responsable Affaires Pharmaceutiques Internationales
2000 - 2001
Responsible for Export Pharmaceutical Affairs
Scandinavia, Australia, New-Zealand, Central and Eastern European countries.
- registration of Medicinal Products and Medical Devices in countries under responsibility,
- follow-up of registrations and regulatory advices,
- up-dating of pharmaceutical files,
- writing and submission of variations.
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Laboratoires Fournier
- Assistant Chef de Projet - Développement – Export
1995 - 2000
Assistant Project Manager - Development - Export
Central European Countries, Latin America, Africa, Taiwan, Philippines.
- development and registration of medicinal products in Export countries: writing of dossiers, up dating of dossiers, submission and follow-up of registrations,
- Business Development Export: licensing of medicinal products in order to complete the Export range.
