Regulatory Affairs Specialist

Adecco Italia Spa – Branch Roma Ovest, for a prestigious multinational of pharmaceutical chemical sector, is looking for a Regulatory Affairs Specialist The 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 teams Required 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 skills Contractual and economic offer: Fixed term contract until december 2024, a subsequent extension will be evaluated. Salary: CCNL Chimico Farmaceutico Liv.D1 / C2 From Monday to Friday / Full Time Rome (EUR) Lingue conosciute: Inglese Competenze: Progettazione / Disegno tecnico - Microsoft Office Disponibilità oraria: Full Time