Regulatory Officer

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

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