Regulatory Affairs Specialist

7 giorni fa


Milan, Italia Altro A tempo pieno

OverviewJoin to apply for the Regulatory Affairs Specialist (L.68/99) role at AstraZenecaAre you ready to make a difference in the world of healthcare? As a Regulatory Affairs Specialist within the Italian Marketing Company, you will play a crucial role in achieving and maintaining regulatory authorizations for new and existing products. You will support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead, ensuring compliance with local legislation and SOPs. Your work will guarantee adherence to GRP, Local and Global SOPs, MC Regulatory Process, Quality Manual, and Italian and European regulations.AccountabilitiesSupport the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead during registration applications for new products, new indications, and extensions, ensuring compliance with national and EU legislation within agreed deadlines.Guarantee the correct maintenance of registered products, including renewals, quality and safety updates, and labelling requirements, under the supervision of the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead.Interact with Italian Regulatory Authorities to resolve product‑related issues, maximizing regulatory authorization effectiveness with line‑manager support if necessary.Review promotional materials from a regulatory perspective to ensure compliance with local legislation and MC Code/SOPs.Engage in competitive intelligence activities.Manage special projects (e.g., MA



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    Are you ready to make a difference in the world of healthcare? As a Regulatory Affairs Specialist within the Italian Marketing Company, you'll play a crucial role in achieving and maintaining regulatory authorizations for new and existing products. You'll support the Head of Regulatory Affairs & Medical Compliance Lead Nominated Signatory GRP Lead, ensuring...


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