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Rabaa M. Al-Rousan Hamed I. Aly Daniela Z. Bazan Adam Brown Wei Minjie Juan F. Castro Dr. Manoj Kumar Barthwal Dr Jagavelu Kumaravelu Zakaria Abd Elmageed Burton M Altura BENJAMIN E. BLASS Charlotte Farris Michael Borenstein prof. dr. A.J.R. Heck Vibha Rani Reza Fassihi Shweta Dang MARC ILIES Adriana Ribeiro Silva SWATI NAGAR View MoreAntonio Imparato
Regulatory Submission Delivery Coordinator
Pharmaceutical Sciences
Oikos Ricerche
Belarus
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.
Pharmaceutical chemist