Biosciences Engineer (INSA Lyon France). Regulatory Affairs Consultant at UCB Pharma SA HQ (Brussels). Regulatory Affairs Consultant at Lundbeck HQ (Copenhagen). Preparation and tracking of submission dossiers ( MAH transfers, variations, renewals and site registrations) for Europe, Latin America, African Countries, Asia and CIS countries Collaboration with QA, Supply and drug safety teams. Develop and maintain work instructions and ways of working on collaboration sites. Regulatory Publishing - eCTD - Adobe Acrobat, ISItoolbox, Extedo eCTDmanager Informatics (C++, Python, Perl, sql, html) Biostatistics and mathematical models (R) Biomedical sciences, molecular modeling (Sybyl, Autodock, Vina, PDBviewer, Hyperchem) Management, business development. Windows, linux.
Regulatory Affairs Consultant and Quality Manager
Since October 2014
Junior Regulatory Affairs Consultant
January 2012 --- December 2014
Consultant at ProductLife Group
Business Development and Regulatory Publishing Consultant
January 2011 --- January 2012
Product Life is a proven European actor in providing process and business services as well as consulting for life sciences companies, as a way to support and improve the regulated processes that bring products to market.
Research in bioinformatics
March 2010 --- August 2010
Docking, Molecular modelling, Laboratories, bioinformatics, programming
Research in informatics and epidemiology
April 2009 --- August 2009
Epidemiology, informatics, programming
June 2008 --- September 2008
Team management, responsibilities, organization.
June 2006 --- July 2006
Engineer in Biomedical from Politecnico di Milano in 2010
Engineering in Biosciences - Bioinformatics and modelling from Institut national des Sciences appliquées de Lyon in 2010