Start-Up Associate II (Italy)

About the role

Allucent helps small-to-medium biopharmaceutical companies navigate clinical trials. It is looking for a Start-Up Associate II (SUA II) to join its A-team in Italy, working in a hybrid or remote setting. The role coordinates and carries out local site start-up activities, including document collection, regulatory authority and ethics committee submission and approval, and acts as the main contact with regulators, investigators and sites until the Site Initiation Visit.

Key responsibilities

• Track start-up progress and milestones in CTMS and file documents in the (e)TMF, and help colleagues do the same
• Prepare, compile and submit regulatory and ethical documentation, and prepare answers to questions from regulators and ethics committees
• Check for updates on regulations and guidelines and circulate them
• Support the Global Regulatory Manager and Global Submission Specialist as needed
• Negotiate and finalise Clinical Trial Agreements, Letters of Indemnification, budgets and other site-level agreements, and obtain site and sponsor signatures
• Collect and review Essential Documents, follow up on discrepancies until resolved, and track shipment authorisation for the investigational product
• Adapt country templates to site needs and communicate contract status to sites and internal staff

Required profile

• Life science degree or equivalent qualification in a related allied health profession
• More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
• Thorough knowledge of local competent authority submission and reporting requirements, and a good understanding of the drug development process
• Fluent Italian and English, with attention to detail and teamwork

What we offer

• Comprehensive benefits package and competitive salary per location
• Departmental study and training budget
• Flexible working hours within reason
• Buddy program, internal growth opportunities and career progression
• Employee referral program, Spot Bonus Award and Loyalty Award programs