Italy
Regulatory Affairs Manager
Pharmaceuticals
Experience
Infa Group SpA (Sifavitor, Labochim, Derivados Quimicos) January 2010 - April 2014
BBraun Medical SpA 2009 - January 2010
GUNA Biotherapeutics 2009 - 2009
Studio SviMM - Farmaffari 2008 - 2009
Skills
ema submission, Regulations, Market Access, variation, Global Regulatory..., Regulatory Analysis, EDQM, CMC Regulatory Affairs, Pharmaceutics, Regulatory Submissions, Business Planning, Module 3, Regulatory Requirements, US monograph, JP monograph, Sop, European Union, eCTD, Regulatory Documentation, Drug substances, CEP, ASMF, DMF, Regulatory Affairs, Clinical Trials, Market Research, APIs, FDA, New Business Development, CTD, Biotechnology, China regulation, Quality System, ICH guideline, Pharmacovigilance, Pharmaceutical Industry, GMP, Canada regulation, Product Marketing, India regulation, GxP, NeeS, Russia regulation, Korean regulation, Ph Eur monograph, Change Control, GDUFA guideline