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Extensive experience in the Pharmaceutical Industry, in the areas of Research and Development, Manufacturing, Regulatory Affairs and Quality in National and International CompaniesEspecialidades: Development, Register, Transfer of Technology of pharmaceutical products in LATAM
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Quality And R&D ManagerSavant Pharm S.A. May 2017 - May 2020ArgentinaResponsible for the quality management system Development, Registration and launching of new products Regulatory Development in LATAM
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Director Of Thecnical OperationsLaboratorios Finadiet Jan 2013 - May 2017ArgentinaResponsible for Operations (Production, Planning, R&D, RA, QC and QA, Selection of Suppliers)Technical Direction -
Regulatory Affairs Manager For South ConeApotex Inc. Dec 2011 - Jan 2013ArgentinaRegistration of new products for the region.Launching Coordination of new products.Regulatory support to operative units.Local Responsible for Pharmacovigilance.Local Brand Management. -
Regulatory Affairs Sr. Manager - Technical DirectorGlenmark Generics Ltd. Aug 2010 - Dec 2011ArgentinaGlobal filing of dossiers for all operative unites. USA, EMA.Registration of new products in Latin-American Markets.Regulatory support to operative units.Local Brand Management.Local Responsible for Pharmacovigilance.Member of R&D team for new products.Technical Direction in Argentina. -
Regulatory Affairs And R&D ManagerFada Pharma May 2009 - Aug 2010ArgentinaDevelopment and Transfer of Technology of new products for the company.Responsible for Registration Process locally and others countries (LATAM, ASEAN).Organization of regulatory structure in Ecuador, Peru, Venezuela, Paraguay, Colombia and Uruguay. Regulatory Support to operative units.Technical Training to Sales force. -
Pharmaceutical Development ManagerRaffo - Monteverde (Grupo Tecnofarma) Jun 2004 - Mar 2009ArgentinaDevelopment of new products (ICH).Transfer Technology to operative units.Optimization of launched products.Corporative Administration of Reference Standards.Technical Support to Regulatory Affairs and Operative Units.APIs Evaluation.Technical Training to Sales force.Technical Support to health authorities in LATAM.Start up in new technologies (RRLC, Stability Program).
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Qc HeadMontpellier Aug 2003 - Jun 2004ArgentinaResponsible for Microbiological and Physicochemical department . SOP’s Edition.Batch Record releasing.
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Analytical Develpment HeadMontpellier Dec 1997 - Aug 2003ArgentinaAnalytical Methods Validation Program.Stability Studies Program.Calibration Program.Reference Standards Program.CTD edition and participation in Registration Process in China, Russia, RSA of Bagó Group.SOP’s Edition.
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Analytical Development Head - Technical DirectorAmarin Corporation Oct 1996 - Dec 1997Argentina-Development and Validation of Analytical Methods-Stability Studies for company products-SOPs edition -
Qc HeadGemepe Mar 1996 - Oct 1996Argentina- Analytical Methods Validation Program- Stability Studies Program - SOP’s Edition- Responsible for Registration process- Responsible for QC units -
R&D Sr. AnalystPhoenix May 1990 - Mar 1996-Development and Validation of Analytical Methods-Stability Studies for company products
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Qc Jr. AnalystLazar Feb 1988 - May 1990Analysis of RM, FP, PM
Leonardo Fullone Skills
Leonardo Fullone Education Details
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Universidad De Palermo9.63 -
Instituto Universitario De La 'Fundación Isalud'9 -
Universidad Tecnológica NacionalManagement -
Ciencias De La Salud
Frequently Asked Questions about Leonardo Fullone
What is Leonardo Fullone's role at the current company?
Leonardo Fullone's current role is Quality and R&D Manager.
What is Leonardo Fullone's email address?
Leonardo Fullone's email address is lf****@****tex.com
What schools did Leonardo Fullone attend?
Leonardo Fullone attended Universidad De Palermo, Instituto Universitario De La 'fundación Isalud', Universidad Tecnológica Nacional, University Of Buenos Aires.
What skills is Leonardo Fullone known for?
Leonardo Fullone has skills like Poe, I+d, Asuntos Normativos, Microsoft Office, Liderazgo De Equipos, Pharmaceutical Industry, Control De Calidad, Validation, Microsoft Excel, Farmacovigilancia, Gmp, Quality Control.
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Leonardo Fullone
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