a highly experienced Regulatory Affairs professional with Pharmaceutical Education (pharm. d., mph, French inspectorate). areas of expertise include gmo and advanced therapy regulations (i.e. usa, europe and international). roles and responsibilities cover all aspects of drug registration: Education and Training of partners, regulatory Strategy, negotiations with regulatory bodies, Preclinical, Clinical, cmc aspects of dossiers, price-Reimbursement and Advertising promotion.
Executive Director Regulatory Affairs - EMEA
Since April 2015
Director Regulatory AffairsJanuary 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 AffairsJanuary 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 AssociateJanuary 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 FranceJanuary 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.
LinkedIn Assessment :
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
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