Junior Regulatory Affairs Specialist

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. Esperienze lavorative: Regulatory Affairs Specialist - 12 mesi Titolo di studio: Laurea Magistrale Lingue conosciute: Inglese: Comprensione Buono Competenze: Word Processor - Elaborazione testi - Word, livello Ottimo Fogli di calcolo / elettronici - Excel, livello Ottimo Farmaco-Scientifico - Farmaceutica, livello Ottimo Disponibilità oraria: Full Time