Remote Start-Up Associate II – Regulatory Affairs (Italy)

Allucent; Lombardia; Hybrid; EUR 42,000 - 62,000; Full time

Job summary

Allucent is seeking a Start-Up Associate II to join our A-team in Italy with hybrid/remote work options.

The SUA II coordinates local site start-up activities, manages regulatory submissions, and acts as the main liaison to regulatory authorities and investigators during the initial phase of a clinical study.

You will track milestones in CTMS, maintain essential documentation, and support regulatory and ethical submissions to enable timely Site Initiation Visits.

Qualifications

• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
• Thorough knowledge of country/region submission and reporting requirements and guidelines.
• Thorough understanding of the drug development process.
• Excellent oral and written communications skills; fluent in Italian and English.
• Attention to detail and ability to work well in a team.

Responsibilities

• Coordinate local start-up activities and regulatory submissions.
• File documents in the (e)TMF and maintain CTMS data.
• Prepare, compile, submit and maintain regulatory documentation for local approvals.
• Assist in preparing country-specific essential documents and respond to agency questions.
• Interact with regulatory authorities and IEC/IRB; ensure compliance with local regulations.

Skills

Fluent Italian & English

Education

Life Science degree or equivalent

Regulatory affairs certification (related)

Job description

Allucent is seeking a Start-Up Associate II to join our A-team in Italy with hybrid/remote work options.

The SUA II coordinates local site start-up activities, manages regulatory submissions, and acts as the main liaison to regulatory authorities and investigators during the initial phase of a clinical study.

You will track milestones in CTMS, maintain essential documentation, and support regulatory and ethical submissions to enable timely Site Initiation Visits.