Contractor Regulatory Operations Associate Milano

Contractor Regulatory Operations Associate
Milano
Lombardia, Milano

Contractor Regulatory Operations AssociateAutore annuncio: Randstad Italia spa

Zona lavoro: Milano

Data pubblicazione: 26 ottobre 2024

Sigla riferimento: CX420005

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.

Responsibilities include:

Initiating, reviewing, and approving regulatory changes through Pfizer enterprise system for changes initiated by or impacting ESQ managed contractors. Providing support for the closure of deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations, and Post approval variations. Acting as the main point of contact for Global Chemistry Manufacturing & Controls (GCMC) department or Local Regulatory Affairs in Pfizer Country Offices for the regulatory activities involving the ESQ contractors. Participating as the Regulatory Expert in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and, if needed, participating in Site Quality visits at the contractors. Settore: manifatturiero & produzione

Categoria: Tecnici specializzati, qualità

Orario di lavoro: Giornata

Contratto: Somministrazione

Numero posti: 1

Luogo di lavoro: Milano

Requisiti: Min. BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical disciplineMin. 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 year with Masters degree)Good verbal & written skillsAdvanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platformsGood command of English language; multilingual is a benefitStrong verbal and written communication skills including presentation skillsAble to work in diverse multi-level, cross-divisional and multi-cultural working environmentAble to report remotely and deliver work independentlyShow strong negotiation skills and customer focusDiplomatic in communication with internal and external customersLa ricerca è rivolta ai candidati ambosessi (L. 903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad. it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).

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