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."

salary range 36,000–46,000 gross annual premio incentive plans other benefits

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

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

CTR Part II submissions for Italy regulatory document review translation review

📌 Regulatory Officer (Bardi)
🏢 Altro
📍 Bardi