Compliance Officer Italian

12 ore fa

Milano, Provincia di Milano; Lombardia, Italia PSI CRO Tempo pieno
Overview In this role you will support Italy's regulatory activities under the EU Clinical Trials Regulation and coordinate CTR Part II submissions. You will work closely with cross-functional teams, regulatory authorities, and vendors to ensure timely and accurate submission packages. The position offers hybrid work in the Milan area and a path to deepen expertise in regulatory submissions for novel medicinal products. You will help drive compliant document reviews, translations, and IP release checks, contributing to successful project starts. This role fits a collaborative, detail-oriented professional aiming to impact clinical research timelines and compliance. Retribuzione / Benefits base salary within range 36,000 – 46,000 EUR bonus and incentive plans hybrid working in Milan area opportunity to contribute to clinical studies/regulatory success Responsabilità Support country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR) Prepare and coordinate CTR Part II submission packages for Italy Communicate with regulatory authorities, project teams and vendors on regulatory matters Review translations of essential documents subject to clinical trial submission Track regulatory project documentation flow Review documents to greenlight IP release to sites Requisiti fondamentali Scientific University degree or equivalent Mandatory experience with CTR Part II submissions for Italy Full working proficiency in English and Italian Proficiency in MS Office Detail-oriented Ability to learn, plan and work in a dynamic team environment Strong communication, collaboration, and problem-solving skills communication collaboration problem-solving CTR Part II submissions regulatory submissions coordination translation review