Overview In this role you will support Italy's regulatory activities under the EU CTR, preparing Part II submission packages and coordinating with authorities, teams, and vendors. You'll review translations and track documentation flow to ensure timely approvals. The position sits in a hybrid Milan-based team focused on enabling clinical research for novel medicines. You will work closely with cross-functional partners to ensure compliant, efficient submissions, contributing to project momentum and site readiness.
Retribuzione / Benefits
base salary 36,000 – 46,000 gross annual
premio
incentive plans
other benefits
Responsabilità
Support Italy country-level regulatory activities under EU 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 clinical trial submission documents
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
Proficiency in English and Italian
Proficiency in MS Office
Detail-oriented
Ability to learn, plan and work in a dynamic team
Strong communication, collaboration, and problem-solving skills
communication
collaboration
problem-solving
CTR Part II submissions
MS Office

📌 Regulatory Officer (Italia)
🏢 Psi Cro
📍 Italia