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

Allucent; Roma; Híbrido; EUR 45.000 - 65.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits

Competitive salaries

Training budget for development

Flexible working hours

Buddy Program

Career progression

Referral program

Spot Bonus program

Loyalty Award

Descripción de la vacante

Allucent is seeking a Start-Up Associate II to join our A-team in Italy, with hybrid/remote options. The SUA coordinates local site start-up activities, handles regulatory submissions to RA/IEC/IRB, and serves as main communicator to investigators and sites through the initial phase of a clinical study.

This role supports document management, regulatory and ethical submissions, and interaction with authorities, while ensuring compliance and timely updates across CTMS and study teams.

Formación

• Requires knowledge of regulatory submission processes for local authorities.
• Fluent in Italian and English with strong written and verbal communication.
• Detail-oriented and capable of working effectively in a cross-functional team.

Responsabilidades

• Coordinate local site start-up activities and maintain timelines in CTMS.
• Prepare, compile, submit and maintain regulatory documentation for local submissions.
• Interact with regulatory authorities and IEC/IRB, and respond to questions.
• Assist in CTMS data entry, document filing, and site communication.

Conocimientos

Regulatory affairs

English & Italian communication

Attention to detail

Team collaboration

Educación

Life Science degree

Descripción del empleo

Allucent is seeking a Start-Up Associate II to join our A-team in Italy, with hybrid/remote options. The SUA coordinates local site start-up activities, handles regulatory submissions to RA/IEC/IRB, and serves as main communicator to investigators and sites through the initial phase of a clinical study.

This role supports document management, regulatory and ethical submissions, and interaction with authorities, while ensuring compliance and timely updates across CTMS and study teams.