Contractor Regulatory Operations Associate - Roma

CONTRACTOR REGULATORY OPERATIONS ASSOCIATE - ROMA Settore: manifatturiero & produzioneCategoria: Tecnici specializzati, qualita'Orario di lavoro: Full TimeContratto: SomministrazioneNumero posti: 1Luogo di lavoro: RomaRandstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Operations Associate, who will be in charge of for regulatory change management/renewal/query activities for products manufactured by External Supply Quality (ESQ) managed contractors. Primary Responsibilities Initiate, review and approve regulatory changes through Pfizer enterprise system for changes initiated by or impacting ESOQ managed contractors; Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations;Main point of contact for GlobalChemistry Manufacturing&Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors;As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESQ managed contractors and if needed, participate in Site Quality visits at the contractors. Requisiti: QualificationsMin. 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 years 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 platforms Fluent command of English language and multi-lingual is a benefit Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment Able to report remotely and deliver work independently Show strong negotiation skills and customer focus Is diplomatic in communication with internal and external customers Expected placement in the Rome office with a fixed-term contract. La ricerca e' rivolta ai candidati ambo (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). Riferimento: CX410397 Titolo di studio minimo: Comune e/o quartiere: Roma