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