Regulatory Specialist
Pubblicato il 09-08-2026 - Experteer Italy in Cusano Milanino
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, xysqume 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
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