Regulatory Officer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8d8ntv

pIn 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.
" /pullisalary range 36,******,000 gross annual /lilibonus /liliincentive plans /liliother benefits /liliPrepare and coordinate CTR Part II submission packages for Italy /liliSupport country-level regulatory activities for Italy under the EU CTR /liliCommunicate with regulatory authorities,



project teams and vendors on regulatory matters /liliReview translations of essential documents subject to clinical trial submission /liliTrack the regulatory project documentation flow /liliReview documents to greenlight IP release to sites /liliScientific University degree or equivalent /liliPrevious experience with CTR Part II submissions for Italy /liliFull working proficiency in English and Italian /liliProficiency in MS Office /liliDetail-oriented with ability to learn and work in a dynamic team /liliStrong communication, collaboration and problem-solving skills /lilidetail-oriented /lilicommunication /liliCTR Part II submissions for Italy /liliregulatory document review /lilitranslation review /li /ul #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8d8ntv