Regulatory Officer
Pubblicato il 28-10-2026 - Psi Cro in Monza
Overview
In this role you drive regulatory submissions for Italy under the EU CTR, supporting the startup of studies for novel medicines. You will work within regulatory and ethics teams to coordinate packages, communicate with authorities, and ensure timely, compliant documentation. The position blends regulatory expertise with cross‑functional teamwork in a hybrid setup near Milan. You help shape efficient processes and accurate submissions that enable trial initiation and IP release.”
Retribuzione / Benefits
- salary range 36,000–46,000 gross annual
- premio
- incentive plans
- other benefits
- hybrid work arrangement
Responsabilità
- Prepare and coordinate CTR Part II submission packages for Italy
- Support country-level regulatory activities for Italy under the EU CTR
- Communicate with regulatory authorities, project teams and vendors on regulatory matters
- Review translations of essential documents subject to clinical trial submission
- Track the regulatory project documentation flow
- Review documents to greenlight IP release to sites
Requisiti fondamentali
- Scientific University degree or equivalent
- Previous experience with CTR Part II submissions for Italy
- Full working proficiency in English and Italian
- Proficiency in MS Office
- Detail-oriented with ability to learn and work in a dynamic team
- Strong communication, collaboration and problem-solving skills
- detail-oriented
- communication
- collaboration
- CTR Part II submissions for Italy
- regulatory document review
- translation review