Overview
In this role you support local study start-up activities for clinical trials, acting as the primary liaison with regulatory bodies and ethics committees through site initiation. You manage regulatory documentation, eTMF/CTMS filing, and site contracts to ensure timely, compliant start-up. You collaborate with cross-functional teams to address questions from authorities and sites, keeping regulatory and ethical requirements up to date. This is a hands-on role at the start of a study that shapes site readiness and study execution.
Retribuzione / Benefits Comprehensive benefits package per location
Competitive salaries per location
Training budget for professional development
Flexible working hours
Buddy program for newcomers
Internal growth opportunities and career progression
Responsabilità Coordinate local start-up activities and maintain trackers in CTMS or similar tools
File and own documents in the (e)TMF and assist team members with filings
Prepare, compile, submit and maintain regulatory documentation for local trials




Interact with regulatory authorities and respond to questions
Prepare and compile ethical submissions to IEC/IRB and address inquiries
Assist in adapting country SIS/ISF to site requirements and support contract processes
Prepare, review and finalize CTAs, LOIs, budgets, and site-level agreements
Obtain necessary signatures and ensure documentation complies with local regs
Prepare Essential Document Package and liaise with Global Reviewer
Track Investigational Product shipment authorization and status
Requisiti fondamentali Life Science degree or equivalent
>2 years of regulatory affairs experience in pharmaceutical/biotech
Strong knowledge of local submission and reporting requirements
Understanding of the drug development process
Fluent Italian and English oral/written communication
Attention to detail and teamwork
excellent written and verbal communication
attention to detail
team player
CTMS tracking
(e)TMF document management
regulat

📌 Start-Up Associate II (Varese)
🏢 Allucent
📍 Varese