Regulatory Officer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8h8h0f

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.
We focus on delivering quality and on-time services across a variety of therapeutic indications.Join our team of experts in regulatory and ethics submissions of clinical studies.
You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.Hybrid working arrangementin Milan areaYour role:Support country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR)Prepare and coordinate CTR Part II submission packages for ItalyCommunicate with regulatory authorities,project teams and vendors on regulatory-related 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 an equivalent combination of education, training and experiencePrevious experience with CTR Part II submissions for Italy is mandatoryFull working proficiency in English and ItalianProficiency in MS Office applicationsDetail-orientedAbility to learn, plan and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsBase salary range:€36,000 – €46,000 gross annual salary.Actual compensation:The salary offered within the stated range will depend on objective, job-related criteria, including demonstrated competencies, qualifications, and skills relevant to the position.Additional compensation:premio, incentive plans, and other benefits may apply.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8h8h0f