Regulatory Affairs and Medical Devices Specialist

• Nov 2018 - Present

Consultancy on Medicinal products: o Planning and follow-up of MRP, DCP, CP and National Procedures for new Marketing Authorizations, Variations and Renewals. o Preparation of technical documentation supporting MA variations (Type IA-IB and Type II) according to the relevant EU Regulation and guideline. o Post-marketing regulatory consultancy: adherence to Italian regulations (traceability project, optical stickers and update of PIL and labelling texts according to Italian rules developments). o Accountable to draft and finalize or review the CMC package for CMC variations of products in development phase; o Support for electronic submission (eCTD, NeeS) and preparation of checklist and e-submission ready documents for different regulatory activities. Consultancy on Medical Devices: o Preparation of technical dossier for CE marking, according to the new Regulation 2017/745 and Directive 93/42/EEC. o Regulatory support for the development of new Medical Devices. o Support to clients for inspections by Authorities and/or other parties. o Revision of promotional materials. Show less

Global Regulatory Affairs Officer

• Jul 2017 - Nov 2018

Planning, submission and follow-up of regulatory procedures of medicinal products for human use, with particular reference to Non-EU Countries. In detail: - Preparation of regulatory documents needed for new registrations, renewals and type I-II variations in French-speaking Africa, Gulf Cooperation Council (GCC), Commonwealth of Indipendent States (CIS) and European Western Balkans (EWB). - Submission of registration dossiers according to Eurasian Economic Union (EAEU) requirements, in the context of the "Bringing into compliance" procedure. - Collaboration with the relevant company departments (in particular Quality Assurance, CMC, Pharmacovigilance), in order to mantain the documentation updated and aligned to the national quality and safety requirements of each Countries. - Support to the affiliates and licensors in critical evaluation of the appropriate regulatory strategies, by respecting the established timelines. Pianificazione, gestione e monitoraggio delle procedure regolatorie relative ai medicinali per uso umano del portfolio aziendale, con particolare riguardo per i paesi non-EU. Nel dettaglio: - Preparazione della documentazione necessaria per nuove registrazioni, rinnovi e variazioni di tipo I-II nei Paesi di responsabilità in Africa Francofona, area Gulf Cooperation Council (GCC), aree Commonwealth of Indipendent States (CIS) ed European Western Balkans (EWB). - Allestimento dei dossier registrativi secondo i requisiti dell’Eurasian Economic Union (EAEU), nell’ambito della tipologia di procedura “Bringing into Compliance”. - Collaborazione trasversale con tutti i dipartimenti aziendali, in particolare Quality Assurance (QA), CMC e Farmacovigilanza, al fine di mantenere la documentazione aggiornata e allineata ai relativi requisiti di Qualità e Safety di ciascun Paese. - Supporto ai licenzianti e alle filiali estere nella valutazione critica delle opportune strategie regolatorie da seguire, assicurando il rispetto delle tempistiche prestabilite. Show less

Tesi Sperimentale

• Sep 2016 - Mar 2017

Tesi sperimentale svolta presso un laboratorio di ricerca del Dipartimento di Farmacia, nella sezione di Chimica Farmaceutica e sotto la supervisione del Prof. Rossello. Ho acquisito conoscenze riguardo la sintesi e protezione selettiva di amminoacidi, sintesi di composti dimerici e glicoconiugati, pratiche che hanno reso necessario l’utilizzo delle tecniche di purificazione come la Cromatografia Flash, Isolute e Preparativa. Ho acquisito inoltre competenze riguardo la caratterizzazione analitica e spettroscopica dei composti organici mediante analisi spettroscopica NMR (1H NMR, 13C NMR, COSY, DEPT-135), TLC, HPLC, UV-vis, IR. Experimental Thesis developed in a research laboratory of Department of Pharmacy, in Pharmaceutical Chemistry's section, under the supervision of Prof. Rossello. During this internship I've gained practical and theoretical skills about aminoacids' synthetis and selective protection, synthetis of dimeric compounds and glycoconiugates. These procedures required purification techniques as Flash chromatography, Isolute Cromatography and Preparative one. I've also gained practical and theoretical skills about Analytical and spectroscopic characterization of organic compounds with NMR spectroscopy (1H NMR, 13C NMR, COSY, DEPT-135), HPLC, TLC, UV-vis, IR. Show less

Tirocinio curricolare

• Oct 2015 - Apr 2016

In questa esperienza di tirocinio ho acquisito competenze nella gestione della farmacia e nell’organizzazione dei prodotti presenti in negozio. Sono stato anche affiancato dal tutor nel dispensare farmaci ed altri prodotti. Ho inoltre acquisito abilità pratiche nella preparazione di farmaci galenici all’interno del laboratorio. In this Internship experience I've gained skills about Pharmacy management, dispensing, with my tutor, drugs and other products. I've also gained practical abilities in the preparation of Galenic Formulations. Show less

Cultural exchange

• 2009 - 2009