Remote Start-Up Associate II (Regulatory) – Italy

Allucent; Roma; Hybrid; EUR 42,000 - 60,000; Full time

Benefits offered by this job

Flexible Working hours

Buddy Program

Career progression

Study/Training budget

Referral program

Loyalty award

Job summary

Allucent seeks a Start-Up Associate II in Italy to coordinate local site start-up activities and manage regulatory submissions with RA/IEC/IRB, acting as the main point of contact for investigators and sites through early study phases.

You will file documents in eTMF, prepare country-specific CTAs and budgets, negotiate with sites, and support the Global Regulatory team while ensuring compliance with local regulations.

Qualifications

• Minimum 2 years of regulatory affairs experience in pharma/biotech.
• Solid understanding of local country submissions and regulatory guidelines.
• Strong communication skills in Italian and English.
• Knowledge of drug development processes and documentation.
• Detail-oriented and able to work well in a team.

Responsibilities

• Coordinate local start-up activities and regulatory submissions to RA/IEC/IRB.
• Prepare and file Essential Documents in CTMS/eTMF and maintain them.
• Interact with regulatory authorities and respond to questions.
• Assist in drafting CTAs, LOIs, budgets and site contracts.
• Ensure compliance with local regulations and update teams on changes.
• Support Global Regulatory Manager and Global Submission Specialist.

Skills

Fluent in Italian

Fluent in English

Attention to detail

Team player

Regulatory knowledge

Education

Life Science degree

Job description

Allucent seeks a Start-Up Associate II in Italy to coordinate local site start-up activities and manage regulatory submissions with RA/IEC/IRB, acting as the main point of contact for investigators and sites through early study phases.

You will file documents in eTMF, prepare country-specific CTAs and budgets, negotiate with sites, and support the Global Regulatory team while ensuring compliance with local regulations.