Regulatory Specialist: CTR Italy, Hybrid (Milan)

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

Vantaggi offerti da questo lavoro

Bonus & incentives

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

English proficiency

Italian proficiency

Detail-oriented

Teamwork

Problem-solving

Communication

Formazione

Scientific University degree

Strumenti

MS Office

Descrizione del lavoro

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