– Knowledge of theoretical regulatory notions both Italian context and International context;
– knowledge of regulations and guidelines;
– knowledge of the company products that are marketed in the International context;
– knowledge of the registration procedure of Bimatoprost eye drops solution (Amiriox®);
– knowledge of post-authorisation activities;
– support to regulatory functions of the company;
– research of the documents;
– familiarity with Artworks and texts;
– check of the documents have to submit for a variation;
– check of the internal company documents;
– check of the company’s promotional material;
– research and learning of the national requirements of different countries;
– training on the UNICOM European project and on the EMA SPOR project;
– training on XEVMPD;
– use of XEVMPD;
– consultation of the MedDRA dictionary;
– training on PMF;
– training on use of the company DMS;
– check of the internal company documents;
– check of the company’s promotional material;
– communication with colleagues from other sectors of the company and with external consultants;
– familiarity with Artworks and texts;
– creation of texts in accordance with current regulations, guidelines and international templates;
– modification of Artworks and texts by the company DMS;
– comparison activity between approved and submitted Artworks and texts at the end of a registration or variation procedure;
– learning how to use eCTD management softwares;
– archiving activity;
– creation and presentation to colleagues of archiving working instructions for the purpose of better organisation of documentation;
– translation into English of the decrees and approvals received in the national phase of a registration procedure or a variation, for archiving and future consultation;
– creation of informative, summary and organizational Word and Excel files;
– support to regulatory functions of the company;
– knowledge of post-authorisation activities;
– application of the guideline of the reg. 1234/2008 for the purpose of classifying a variation for a medicinal product;
– compilation of an eAF, creation of a Cover Letter and all the documentation needed for the purpose of submitting a variation for a medicinal product;
– check of the documentation before submitting a variation to the HA(s);
– learning about submitting a variation through the MHRA portal;
– learning about the creation of zero variation for AIFA;
– learning how to submit a variation through the AIFA Front End.