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Consultante Affaires Réglementaires et Pharmaceutiques at ATESSIA, Life Science Advisors- Claim this Profile
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Experience
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ATESSIA, Life Science Advisors
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France
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Business Consulting and Services
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1 - 100 Employee
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Consultante Affaires Réglementaires et Pharmaceutiques
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Aug 2021 - Present
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Planetpharma
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India
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Biotechnology Research
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1 - 100 Employee
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Responsable Adjoint Distribution
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Jan 2017 - Aug 2021
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Ethypharm
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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European Procedures Coordinator - Regulatory Affairs
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Oct 2013 - Jan 2017
Hybrid and generic MA Applications through European procedures (DCP, MRP): new applications, slots, renewals, licences variations and transfer Follow-up of ongoing applications during the European phase and until the finalization of the national phases (follow-up with health Authorities, partners, manufacturing sites) Module 1: wrote Administrative and Prescribing Information of MA Scientific Advice Applications ECTD submission ( eCTDXPress, EURS Validator, LORENZ eValidator, Eudralink, CESP), according to national requirements European Regulatory Intelligence Show less
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Laboratoires Expanscience
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France
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Personal Care Product Manufacturing
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700 & Above Employee
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International Regulatory Affairs Pharmacist
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Sep 2011 - Oct 2013
New application, renewal and variation submissions of Marketing Authorization in Europe (DCP, MRP, national) and export( CIS, Asia and Africa) Validation of packaging XEVMPD : submission of details for all the products in EU Regulatory Intelligence New application, renewal and variation submissions of Marketing Authorization in Europe (DCP, MRP, national) and export( CIS, Asia and Africa) Validation of packaging XEVMPD : submission of details for all the products in EU Regulatory Intelligence
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Biogaran
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France
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Marketing Trainee (health professionnals)
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Jun 2011 - Aug 2011
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Education
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Université de Caen Basse Normandie
Diplôme d'Etat de Docteur en Pharmacie, Filière Industrie -
Université René Descartes (Paris V)
Master 2 Droit des industries des produits de santé -
IAE de Caen
Master Administration des Entreprises