Regulatory Submission Delivery Coordinator
Pharmaceutical chemist with a solid cultural and regulatory affairs background in global pharmaceutical companies. Currently I am working in GSK as Regulatory Submission Delivery Coordinator. Previously I worked as Regulatory Affairs Associate at PAREXEL (London, UK ), and before in the regulatory department at Abbott Laboratories (Rome, Italy). My principal expertise including: preparation of new MA application, CMC activities: review, draft and final submission of regulatory dossiers sections (module 3- 3.2S Drug Substance and 3.2.P Drug Product), managing of post- marketing variations (Type IA,IB, IAIN, Type II,Renewals), prepare response to questions from HA, extension of indications. I am always highly self-motivated to improve my knowledge, I show positive attitude towards new challenges, I am a really good team member and I like to create an extraordinary and unique relationship with all the stakeholders involved in my same project.