Regulatory Affairs Specialist - Italian & EU

22 ott - Roma
ALFASIGMA

Alfasigma is seeking a Regulatory Affairs Specialist to manage local Italian product regulatory activities for Rx and OTC lines. You will prepare and submit dossiers, variations, and renewals while maintaining high data quality and regulatory compliance.
You will collaborate with Quality, Medical Affairs, Market Access and Regulatory teams to navigate EU/Italy guidelines, support promotional material reviews, and monitor regulatory changes for portfolio impact.

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