Regulatory Start-Up Associate II (Italy)

Allucent; Lazio; On-site; EUR 45,000 - 60,000; Full time

Benefits offered by this job

Flexible Working hours

Career growth opportunities

Competitive salary per location

Job summary

Allucent is seeking an experienced Regulatory Affairs Coordinator to support site start-up activities for clinical trials. You will manage regulatory documents, track milestones in CTMS/eTMF, and prepare local submissions to regulators in coordination with the Global Regulatory team.

A Life Science degree and 2+ years in regulatory affairs are required, with fluency in Italian and English. The role offers flexible hours, competitive salaries per location, and growth opportunities within Allucent.

Qualifications

• Life Science degree or equivalent qualification.
• 2+ years of regulatory affairs experience in pharma/biotech.
• Fluent in Italian and English.
• Thorough knowledge of local/regional submission requirements.

Responsibilities

• Track regulatory information, data and milestones in CTMS/eTMF for Start-Up activities.
• Prepare, compile and maintain regulatory documentation for local submissions.
• Interact with regulatory authorities and IEC/IRB as needed.
• Assist in contracting and ethics documentation (CTAs, LOIs, budgets) for sites.
• Coordinate with GRM/GSS and cross-functional teams to meet milestones.

Education

Life Science degree or equivalent qualification

Tools

CTMS

eTMF

Job description

Allucent is seeking an experienced Regulatory Affairs Coordinator to support site start-up activities for clinical trials. You will manage regulatory documents, track milestones in CTMS/eTMF, and prepare local submissions to regulators in coordination with the Global Regulatory team.

A Life Science degree and 2+ years in regulatory affairs are required, with fluency in Italian and English. The role offers flexible hours, competitive salaries per location, and growth opportunities within Allucent.