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Shire AG
- Associate Director Regulatory Affairs
2011 - maintenant
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Novartis Consumer Health
- Head Global Regulatory Affairs, Established Products Category
RUEIL MALMAISON
2010 - 2011
• Responsible for the development and execution of the projects of the Established Products Category.
• Responsible for all regulatory regional (EU, US and Emerging Markets) lifecycle management activities of the Category.
• Line management of managers and associates (approximately 12 persons).
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Novartis Consumer Health
- Global Regulatory Leader
RUEIL MALMAISON
2009 - 2010
• Lead of the global regulatory team for the development and execution of the projects of one therapeutic category.
• Responsible for ensuring that all regulatory regional lifecycle management activities are timely completed by the global regulatory team.
• Coordination of the therapeutic category global regulatory team.
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Novartis Consumer Health
- Manager Regulatory Affairs, EU Liaison
RUEIL MALMAISON
2008 - 2009
• Responsible for the EU regulatory strategy of the projects of one therapeutic category.
• Coordination of local regulatory counterparts maintenance activities (variations, last EU renewals,…).
• Line Management of 1 to 2 EU Regulatory Affairs Officers.
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Novartis Consumer Health
- Manager Regulatory Affairs
RUEIL MALMAISON
2007 - 2008
• Responsible of a range of products in EU and ROW (Rest Of the World, i.e. non EU / non US).
• For one global brand, responsible for the regulatory strategy of new projects in EU & ROW.
• Line management of 1 to 2 Regulatory Affairs Officers.
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Novartis Consumer Health
- Senior Regulatory Affairs Officer
RUEIL MALMAISON
2006 - 2007
• Coordination of new registrations in EU (MRP), geographical expansion, and switches to OTC (including the preparation of several registration, Rx to OTC switch and variation dossiers).
• Coordination of EU and ROW local regulatory counterparts maintenance activities.
• Project team member for e-CTD publishing tool implementation.
• Coaching of junior officers.
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Novartis Consumer Health
- Regulatory Affairs Officer
RUEIL MALMAISON
2002 - 2006
• Coordination of new registrations in EU (MRP), geographical expansion, and switches to OTC (including the preparation of several registration, Rx to OTC switch and variation dossiers).
• Coordination of EU and ROW local regulatory counterparts maintenance activities.
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Novartis Pharma SAS
- Regulatory Affairs trainee
RUEIL MALMAISON
2001 - 2001
• Preparation of a dossier for transfer of manufacturing site and CMC variations.
• QA-regulatory compliance for the activities performed in the manufacturing site of Huningue.
