Regulatory Officer

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.