Regulatory Officer

Psi CRO; Milano; On-site; EUR 36,000 - 46,000; Full time

Benefits offered by this job

Bonus & incentives

Job summary

PSI is seeking a regulatory submissions specialist in the Milan area to facilitate start-up activities for clinical studies under the EU CTR framework. The role involves coordinating Italy CTR Part II submissions, communicating with authorities, project teams and vendors, and ensuring accurate document translations.

The candidate should have a scientific degree, English and Italian proficiency, strong MS Office skills, and a detail-oriented, collaborative mindset to support regulatory workflows

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.

Responsibilities

• 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.

Skills

English proficiency

Italian proficiency

Detail-oriented

Teamwork

Problem-solving

Communication

Education

Scientific University degree

Tools

MS Office

Job 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 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.