Regulatory Officer

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

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 annualbonusincentive plansother benefitsPrepare and coordinate CTR Part II submission packages for ItalySupport country-level regulatory activities for Italy under the EU CTRCommunicate with regulatory authorities,



project teams and vendors on regulatory mattersReview translations of essential documents subject to clinical trial submissionTrack the regulatory project documentation flowReview documents to greenlight IP release to sitesScientific University degree or equivalentPrevious experience with CTR Part II submissions for ItalyFull working proficiency in English and ItalianProficiency in MS OfficeDetail-oriented with ability to learn and work in a dynamic teamStrong communication, collaboration and problem-solving skillsdetail-orientedcommunicationCTR Part II submissions for Italyregulatory document reviewtranslation review#J-18808-Ljbffr

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