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    Junior Regulatory Affairs Specialist - Lazio, Italia - Adecco

    Adecco
    Adecco Lazio, Italia

    1 giorno fa

    Adecco background
    Descrizione
    Adecco italia Spa is looking for an important client in the pharmaceutical sector aJUNIOR REGULATORY AFFAIRS SPECIALISTBasic 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 C- Annual salary 32k. Start date 15 april 2024.

    Esperienze lavorative:
    Regulatory affairs specialist - 12 mesiTitolo di studio:Laurea MagistraleLingue conosciute:Inglese: Comprensione BuonoCompetenze:Word Processor - Elaborazione testi - Word, livello OttimoFogli di calcolo / elettronici - Excel, livello OttimoFarmaco-Scientifico - Farmaceutica, livello OttimoDisponibilità oraria: Full Time
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