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 ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors. 

Min. BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical discipline

Min. 6 years of experience in GXP setting  (QA/QC/production) and/or CMC/Regulatory Affairs role (or 5 years with Masters 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

Preferred requirements:  Experience in chemical API fields

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).