Regulatory Officer

psicro· Regulatory
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📍 Milan, Lombardy, ItalyFull time💰 EUR 36K–46K

About this role

Company Description

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 arrangement in 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: bonus, incentive plans, and other benefits may apply.

    Please submit your CV in English.

    Frequently Asked Questions

    What is the salary for the Regulatory Officer role at psicro?
    The listed salary for this Regulatory Officer position at psicro is EUR 36K–46K. This is an Full time role.
    Where is the Regulatory Officer position at psicro located?
    This Regulatory Officer role at psicro is based in Milan, Lombardy, Italy. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
    Is the Regulatory Officer role at psicro full-time or part-time?
    This is listed as a Full time position. It is posted as a Regulatory Officer role in the Regulatory department at psicro.
    Which team or department does the Regulatory Officer at psicro belong to?
    This Regulatory Officer position is part of the Regulatory department at psicro. See the full job description for more information about the team structure and responsibilities.
    How do I apply for the Regulatory Officer position at psicro?
    Click the "Apply Now" button on this page. You will be redirected to psicro's official application portal hosted on smartrecruiters where you can submit your application directly.
    When was the Regulatory Officer job at psicro posted?
    This Regulatory Officer position at psicro was posted on Oct 2, 2026. Apply as soon as possible — early applications are often reviewed first.
    Regulatory Officer
    psicro · 💰 EUR 36K–46K
    Apply for this role ↗

    You'll be redirected to psicro's official application page on SmartRecruiters.