Start-Up Regulatory Associate II - Italy (Hybrid/Remote)

Allucent; Milano; Ibrido; EUR 45.000 - 62.000; Tempo pieno

Descrizione del lavoro

Allucent seeks a Start-Up Associate II (SUA II) in Italy to coordinate local site start-up activities for clinical trials. You will manage regulatory submissions, maintain essential documents, and liaise with RA/IEC/IRB and investigators during the initial phase of studies.

You will ensure compliance with local regulations, support ethical documentation, and help with contract and budget processes while working in a hybrid/remote setup.

Competenze

• Life Science degree or equivalent qualification.
• 2+ years regulatory affairs experience in pharma/biotech.
• Knowledge of local submission and reporting requirements.
• Understanding of the drug development process.
• Fluent in Italian and English.
• Strong oral and written communication and teamwork.
• Attention to detail and accuracy.

Mansioni

• Coordinate and perform local regulatory submissions.
• File and maintain regulatory documents in CTMS/eTMF.
• Interact with regulatory authorities and IEC/IRB.
• Prepare country-specific regulatory and contractual documentation.
• Support start-up activities, contract review and country adaptations.

Conoscenze

Regulatory knowledge

Drug development

Communication

Attention to detail

Team player

Italian language

English language

Formazione

Life Science degree

Descrizione del lavoro

Allucent seeks a Start-Up Associate II (SUA II) in Italy to coordinate local site start-up activities for clinical trials. You will manage regulatory submissions, maintain essential documents, and liaise with RA/IEC/IRB and investigators during the initial phase of studies.

You will ensure compliance with local regulations, support ethical documentation, and help with contract and budget processes while working in a hybrid/remote setup.