Contractor Regulatory Operations Associate (Fixed Term Contract) Lazio

Contractor Regulatory Operations Associate (Fixed Term Contract)
Roma
Lazio, Lazio

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

Contractor Regulatory Operations Associate.

Location: Rome (hybrid work).

Is offered: initial fixed-term contract of 9 months. Annual salary: €34, 000 - €40, 000, commensurate with experience, in accordance with the chemical collective bargaining agreement.

What will you be responsible for? 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 Global Chemistry Manufacturing & Controls (GCMC) department 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 meetings for ESQ managed contractors and if needed, participate in Site Quality visits at the contractors. What requirements are we looking for? min. BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical discipline;min. 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 years with Master's degree);good verbal & written skills;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;strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment;ability to report remotely and deliver work independently;demonstrates strong negotiation skills and customer focus;diplomatic communication style with both internal and external customers. . 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).