Adecco italia Spa is looking for an important client in the pharmaceutical sector a JUNIOR REGULATORY AFFAIRS SPECIALIST Basic Functions & Responsibility (may not be limited to) ? Be responsible for the management of the authorized products through timely submission of variations, application renewals and supplemental marketing authorizations. ? Carry out linguistic checks, high quality review of translations and QRD checks on Summary of Product Characteristics and Patient Information Leaflets. ? Timely preparation and maintenance of local Summary of Product Characteristics, Patient Information Leaflets, packaging material and other applicable Regulatory documents. ? Perform review of artworks and relevant artwork management. ? Keep Regulatory files and archives updated and complete and stay informed about relevant EU and local regulations and guidelines. ? Secure timely and adequate information sharing of Regulatory items related to deletions and or product suspensions. ? Ensure compliance with the Company procedures and timely completion of the Company professional trainings. Job Requirements ? Master degree in pharmacy or other life science or equivalent. ? Minimum 1 year in a regulatory position with sufficient working knowledge of the subject area to require minimal supervision from the Manager. ? Knowledge of Italian and European Regulatory procedures (NAT, CAP, MRP/DCP). ? Be capable of using of using the different Company database and systems which are instrumental for a compliant management of the daily Regulatory activities. ? Good verbal and written communication skills are essential, as are good organizational and planning abilities. ? Attention to detail and flexibility in managing different deadlines at the same time. ? Capable of working both alone and as part of a team. ? The candidate must be proficient in Italian and English, as well as be capable of PC use with regard to word-processing, spreadsheets and database applications. ? A sound appreciation of the interactions and relationships of the dept with other groups internally is expected. We offer a fixed-term contract for maternity replacement. Level C2 - Annual salary 32k. Start date 15 april 2024. Data inizio prevista: 15/04/2024 Categoria Professionale: Scientifico / Farmaceutico Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA Città: Roma (Roma) Esperienza lavorativa: Regulatory affairs specialist - 12 mesi Istruzione: Laurea Magistrale Conoscenze linguistiche: Inglese - Livello Buono Competenze richieste: Word Processor - Elaborazione testi - Word, livello OttimoFogli di calcolo / elettronici - Excel, livello OttimoFarmaco-Scientifico - Farmaceutica, livello Ottimo Disponibilità oraria: Full Time I candidati, nel rispetto del D.lgs. 198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere l'informativa sulla privacy consultabile sotto il form di richiesta dati della pagina di candidatura (Regolamento UE n. 2016/679). ATTENZIONE: Abbiamo rilevato la presenza in rete di molti annunci falsi; prendi visione dei nostri consigli per riconoscere i tentativi di truffa sulla pagina dedicata al phishing su adecco.it. Adecco Italia S.p.A. (Aut. Min. Prot. N.1100-SG del 26.11.2004).
