Executive Director Regulatory Affairs - EMEA
Since April 2015
Director Regulatory Affairs
January 2007 --- March 2015
Strategize on Global (USA-EU-Canada-Rest of the World) GMO / Gene Therapy / Biotechnology products drug development/registration Ensure strategies are applied (coordinate activities) Manage a Regulatory Affairs Manager Set budgets and resources related to these activities Support Business Development as appropriate
Associate Director Regulatory Affairs
January 2005 --- January 2007
Management of the IV Therapy European Team (4 Regulatory Affairs Specialists) in order to ensure: • Manage the European IV Therapy portfolio (+/- 80 products) • Provide Regulatory input in the optimisation process of Baxter’s IV Therapy portfolio Participation to departmental changes and interfacing activites • Active involvement in working groups for setting processes, SOPs and training (i.e. Global Change Control, Company Core Data Sheet, Electronic Data Management Systems (Publishing, Archiving)) • Set contract agreements with consultants • Manage budgets (budget fees, EU-IVT dept., Six-Sigma working groups dedicated to optimizing/reducing costs related to Regulatory Processes)
Manager Regulatory Affairs (Global)
January 2002 --- January 2005
• Global Regulatory Leader for CellCept® - Immunosuppressive Agent preventing transplant rejection and new Auto Immune Diseases indications (Orphan Indications such as Myasthenia Gravis, Lupus). • Strategize on development of new products in a global regulatory environment (organize and lead meetings w/ FDA, EMEA, National Agencies) and deal with competitors. Products comprise New Chemical Entities in Pulmonary arena (Retinoid Derivative in Chronic Obstructive Pulmonary Disease – Immunomodulator (VCAM) for Asthma). Establish Global Development Plans (preclinical and clinical Phase I through IV).
Senior Regulatory Affairs Associate
January 1997 --- July 2002
Having worked in Cambridge (USA) for 2 yrs and EU HQ (Paris) for 3.5 yrs Supervision of two Regulatory Affairs Associates in order to ensure: Regulatory activities for Avonex™ • Ensure submission of new marketing applications to the EMEA (centralised procedure). • Ensure maintenance of Avonex™ on the EU market. Drug Development activities • Plan, coordinate, prepare and submit clinical trial applications in order to ensure appropriate clinical investigation of Avonex™ as defined by the product development program. • Participate in the Project Team and provide European regulatory strategy for the Avonex™ new development programs. Program management activities • Lead cross departments group for operational plans for market launch of two additional products.
Regulatory Affairs Associate France
January 1995 --- January 1997
Cover all regulatory activities related to contacts with French Health Authorities (AFSSAPS), Ensure the overview of transfer and integrity of the regulatory files; review and approval of promotional material subsequent to the merger between Duphar S.A. and Solvay Pharma S.A.
Masters Public Health in Health Law/Economics (Europe/USA) from Université Paris Sud (Paris XI) in 1995
Lieutenant in Blood Banking/Transfusion Medicine Residency Program from Centre de transfusion sanguine des armees (CTSA)/French Military Blood Transfusion Center - Clamart in 1994
Pharm D in Pharmacy from Université catholique de Louvain in 1993
in from Lycee a Bernay in 1988