contractor regulatory operations associate (fixed term contract)

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 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. 

Qualifications

• 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 
• Able to report remotely and deliver work independently
• Show strong negotiation skills and customer focus
• Is diplomatic in communication with 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).