Contractor regulatory manager 12 mesi roma Luogo 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 Manager.Expected placement at the Rome office with initial fixed-term contract (12 months). Position according to the chemical collective bargaining agreement commensurate with experience.Hybrid work expectedRetribuzione annua: 40000€ - 50000€esperienzada 6 a 10 anniresponsabilitàPrimary Responsibilities Initiate, review and approve regulatory changes through Pfizer enterprise system (i.e PDM) 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 Global Chemistry Manufacturing & Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices for the regulatory activities involving the ESOQ contractors. As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors. Support and Perform Lot Disposition for Biotech semi finished and finished products (if applicable). qualificheBasic qualifications: Master’s degree in Science, Engineering, Pharmaceutical Sciences or related technical discipline Min. 8 years of experience in GXP setting and/or Regulatory Affairs role At least 4 years of Product Quality Assurance experience in a GMP environment Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms Good command of English language and multi-lingual is a benefit Shows strong negotiation skills and is diplomatic in communication with internal and external customers Strong verbal and written communication including presentation skills Demonstrated personal leadership to manage cross functional project Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor Able to report remotely and deliver work independentlyPreferred Qualifications: Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure Supervisory experience desirable Up to 10% travel if required Has a broad GMP and technical know-how to handle emerging issues Developing ability to resolve conflicts La 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).livello di studioLaurea II Liv, Laurea a ciclo unico - no requirements Titolo di studio minimo: Comune e/o quartiere: Roma Link annuncio: https://www.lavoratorio.it/annuncio-lavoro/contractor-regulatory-manager-12-mesi-roma-roma/17507461.html