Regulatory Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/786uc2

ppIn 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.
/pulliFull-time 39 hours per week /liliSalary range 38,000 to 50,000 gross per year /liliShort Term Incentive Plan /liliSupport local implementation and maintenance of centrally authorized products with Italian regulatory alignment /liliManage local lifecycle activities including variations, renewals,



and post-approval changes with Global Regulatory Affairs /liliReview and approve translated product information texts and packaging artwork for compliance /liliCollaborate on review/approval of promotional materials in line with regulations and procedures /liliMaintain regulatory documentation and update internal systems timely /liliAssist internal stakeholders on local regulatory requirements to support business objectives /liliSupport Regulatory Intelligence by monitoring regulatory changes /liliContribute to RMP educational material development with Medical Affairs /liliDevelop and review local SOPs, Working Instructions, and regulatory processes /liliSupport local Pharmacovigilance processes and ESP agreements /liliAssist in inspections, audits, and compliance checks for PV activities /lili2-5 years of experience in Regulatory Affairs in pharma /liliExperience with promotional material review processes is a plus /liliFluent in Italian and English (written and spoken) /liliProficient with Microsoft Office /liliAbility to work independently and collaboratively with RA/QA/PV teams /li /ul /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/786uc2