Regulatory Specialist

Location: Cusano

In this role you support regulatory and operational activities to keep medicinal products and devices compliant with Italian and European requirements. You will interact with internal teams and external partners to maintain product compliance, manage regulatory submissions, and ensure timely pharmacovigilance adherence. You will work across the lifecycle, contributing to variations, renewals, and post-approval changes while aligning with global regulatory standards.

This position offers impact in shaping patient access to rare-disease therapies within a collaborative, growth-oriented environment.
Full-time 39 hours per week
Salary range 38,000 to 50,000 gross per year
Short Term Incentive Plan
Support local implementation and maintenance of centrally authorized products with Italian regulatory alignment
Manage local lifecycle activities including variations, renewals, and post-approval changes with Global Regulatory Affairs
Review and approve translated product information texts and packaging artwork for compliance
Collaborate on review/approval of promotional materials in line with regulations and procedures
Maintain regulatory documentation and update internal systems timely
Assist internal stakeholders on local regulatory requirements to support business objectives
Support Regulatory Intelligence by monitoring regulatory changes
Contribute to RMP educational material development with Medical Affairs
Develop and review local SOPs, Working Instructions, and regulatory processes
Support local Pharmacovigilance processes and ESP agreements
Assist in inspections, audits, and compliance checks for PV activities
2-5 years of experience in Regulatory Affairs in pharma

Experience with promotional material review processes is a plus
Fluent in Italian and English (written and spoken)
Proficient with Microsoft Office
Ability to work independently and collaboratively with RA/QA/PV teams

#J-18808-Ljbffr