Contractor Regulatory Operations Associate - Fixed Term Contract Milano

Contractor Regulatory Operations Associate - Fixed Term Contract
Milano
Lombardia, Milano

Autore annuncio: Randstad Italia spaZona lavoro: Milano, MilanoData pubblicazione: 04 dicembre 2024Sigla riferimento: CX428982Descrizione offerta:Settore: manifatturiero produzioneCategoria: Tecnici specializzati, qualitàOrario di lavoro: Full TimeContratto: SomministrazioneNumero posti: 2Luogo di lavoro: MilanoRandstad 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. Placement expected at the Milan office with an initial fixed-term contract (6 months) with the possibility of extension. Responsibilities include:Initiate, review, and approve regulatory changes through Pfizer's 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. Act as the main point of contact for Global Chemistry Manufacturing Controls (GCMC) department or Local Regulatory Affairs in Pfizer Country Offices (Single market products) for 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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