Regulatory Start-Up Associate II – Italy (Hybrid)

Allucent; United States; Hybrid; USD 45,000 - 68,000; Full time

Benefits offered by this job

Comprehensive benefits package

Flexible working hours

Buddy Program and career development

Growth opportunities

Job summary

Allucent is seeking a Start-Up Associate II to coordinate local site start-up activities and regulatory submissions across Italy. The role acts as the main liaison with RA/IEC/IRB and site investigators during the initial phase of a clinical study until Site Initiation Visit.

The candidate will manage document collection, eTMF filing, and preparation of regulatory documentation, while ensuring compliance with local regulations and timelines.

Qualifications

• 2+ years in regulatory affairs in pharma/biotech
• Excellent communication in Italian and English
• Strong understanding of country/region regulatory submissions and guidelines
• Thorough knowledge of drug development process
• Detail-oriented with ability to work in a team

Responsibilities

• Coordinate local site start-up activities and regulatory submissions.
• Manage document collection and eTMF filing as document owner.
• Interact with RA/IEC/IRB and investigators across initial phase of study.
• Prepare and review Clinical Trial Agreements (CTAs), budgets, and site contracts.
• Track milestones and updates in CTMS and share with study teams.
• Ensure updates are communicated and compliant with local regulations.

Skills

Regulatory affairs experience

Life science degree

Attention to detail

Fluent in Italian

Fluent in English

Team player

Regulatory knowledge

Education

Life Science degree or equivalent qualification

Job description

Allucent is seeking a Start-Up Associate II to coordinate local site start-up activities and regulatory submissions across Italy. The role acts as the main liaison with RA/IEC/IRB and site investigators during the initial phase of a clinical study until Site Initiation Visit.

The candidate will manage document collection, eTMF filing, and preparation of regulatory documentation, while ensuring compliance with local regulations and timelines.