Regulatory Affairs Specialist

Adecco Italia Spa – Branch Roma Ovest, for a prestigious multinational of pharmaceutical chemical sector, is looking for aRegulatory 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 responsabilities:• 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. D1From Monday to Friday / Full TimeRome (EUR)Lingue conosciute:IngleseCompetenze:Word Processor - Elaborazione testi - WordFogli di calcolo / elettronici - ExcelFarmaco-Scientifico - FarmaceuticaDisponibilità oraria: Full TimeCCNL: Chimica - Farmaceutica IndustriaLivello contratto: D1 Livello D1