Regulatory Officer

Psi CRO; Bardi; Hybrid; EUR 36,000 - 46,000; Full time

Benefits offered by this job

Bonus

Incentive plans

Other benefits

Job summary

Psi CRO is seeking a Regulatory Submissions Specialist to drive CTR Part II submissions for Italy under the EU CTR. The role collaborates with regulatory and ethics teams to coordinate packages, communicate with authorities, and ensure timely, compliant documentation in a hybrid setup near Milan.

You will review translations, track documentation flow, and support IP release readiness, leveraging English and Italian language skills and MS Office proficiency in a dynamic team environment.

Qualifications

• Scientific University degree or equivalent.
• Previous experience with CTR Part II submissions for Italy.
• Full working proficiency in English and Italian.
• Detail-oriented with ability to learn and work in a dynamic team.
• Strong communication, collaboration and problem-solving skills.

Responsibilities

• Prepare and coordinate CTR Part II submission packages for Italy.
• Support country-level regulatory activities for Italy under the EU CTR.
• Communicate with regulatory authorities, project teams and vendors on regulatory 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

Communication skills

Team collaboration

Detail-oriented

Education

Scientific University degree

Tools

MS Office

Job description

In this role you drive regulatory submissions for Italy under the EU CTR, supporting the startup of studies for novel medicines. You will work within regulatory and ethics teams to coordinate packages, communicate with authorities, and ensure timely, compliant documentation. The position blends regulatory expertise with cross‑functional teamwork in a hybrid setup near Milan. You help shape efficient processes and accurate submissions that enable trial initiation and IP release.”

• salary range 36,000–46,000 gross annual
• bonus
• incentive plans
• other benefits
• Prepare and coordinate CTR Part II submission packages for Italy
• Support country-level regulatory activities for Italy under the EU CTR
• Communicate with regulatory authorities, project teams and vendors on regulatory 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
• Scientific University degree or equivalent
• Previous experience with CTR Part II submissions for Italy
• Full working proficiency in English and Italian
• Proficiency in MS Office
• Detail-oriented with ability to learn and work in a dynamic team
• Strong communication, collaboration and problem-solving skills
• detail-oriented
• communication
• CTR Part II submissions for Italy
• regulatory document review
• translation review