Compliance Officer Italian
12 ore fa
Milano, Provincia di Milano; Lombardia, Italia
PSI CRO
Tempo pieno
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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