Regulatory Officer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8d817s

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.
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Retribuzione / Benefits
salary range 36,******,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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8d817s