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.
Job Description
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 area
Your role:
Support country-level regulatory activities for Italy under the EU Clinical Trials Regulation (CTR)
Prepare and coordinate CTR Part II submission packages for Italy
Communicate with regulatory authorities,project teams and vendors on regulatory-related 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
Qualifications
Scientific University degree or an equivalent combination of education, training and experience
Previous experience with CTR Part II submissions for Italy is mandatory
Full working proficiency in English and Italian
Proficiency in MS Office applications
Detail-oriented
Ability to learn, plan and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Additional Information
Base 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.

📌 Regulatory Officer (Italia)
🏢 Altro
📍 Italia