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    Regulatory Affairs Specialist - Lazio, Italia - Adecco

    Adecco
    Adecco Lazio, Italia

    4 giorni fa

    Adecco background
    Descrizione
    Adecco Italia Spa – Branch Roma Ovest, for a prestigious multinational of pharmaceutical chemical sector, is looking for a Regulatory Affairs SpecialistThe chosen candidate, under general supervision responsible for the local coordination and the preparation of documents/packages for regulatory submissions, review and evaluate technical and scientific data and reports required for local submission in support of products

    Main responsibilities:

    • Supports regulatory project plan execution
    • Maintain awareness of regulatory requirements and ensure continued learning
    • Maintain regulatory files in a format consistent with requirements
    • Participate as an active team member of project teams as required
    • Compile and prepare responses to questions from regulatory authorities according to plan
    • Edit and proofread regulatory documentation
    • Assist in preparation and review of labeling and other departmental documents
    • Compile under supervision regulatory documents for submission
    • Track status and progress of regulatory documentation
    • Prepare and review AdProm materials for compliance with local regulations
    • Understand Regulatory Affairs' position in small project teamsRequired skills:
    • Bachelor's degree in a relevant scientific discipline
    • Regulatory experience preferably within a healthcare environment
    • Knowledge of regulations
    • Scientific knowledge
    • Administrative and project management skills
    • Ability to contribute to multiple projects from a regulatory affairs perspective
    • Ability to multitask and prioritize
    • Interpersonal and communication skills
    • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
    • Proofreading and editing skillsContractual and economic offer: Fixed term contract until december 2024, a subsequent extension will be evaluated

    Salary:
    CCNL Chimico Farmaceutico Liv.
    D1 / C2From Monday to Friday / Full Time Rome (EUR)

    Lingue conosciute:
    IngleseCompetenze:Progettazione / Disegno tecnico - Microsoft OfficeDisponibilità oraria: Full Time
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