Contractor Regulatory Operations Associate Milano

Contractor Regulatory Operations Associate
Milano
Lombardia, Milano

Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Operations Associate. The candidate will be in charge of regulatory change management, renewal, and query activities for products manufactured by External Supply Quality (ESQ) managed contractors.

ResponsibilitiesInitiate, review and approve regulatory changes through Pfizer enterprise system for changes initiated by or impacting ESQ managed contractors. Provide support for the closure of deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations, and Post approval variations. Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) department or Local Regulatory Affairs in Pfizer Country Offices (Single market products) for the regulatory activities involving the ESQ contractors. As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and if needed, participate in Site Quality visits at the contractors.

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