Italy CTR Part II Submissions Specialist

Psi CRO; Bardi; Ibrido; EUR 36.000 - 46.000; Tempo pieno

Vantaggi offerti da questo lavoro

Bonus

Incentive plans

Other benefits

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

English proficiency

Italian proficiency

Communication skills

Team collaboration

Detail-oriented

Formazione

Scientific University degree

Strumenti

MS Office

Descrizione del lavoro

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.