Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Operations Associate, will be in charge of for regulatory change management/renewal/query activities for products manufactured by External Supply Quality (ESQ) managed contractors.
Experience in the API sector is preferred.
The position will be offered with a permanent contract in temporary employment (staff leasing) and classification according to the national collective labor agreement for chemical workers.
Retribuzione annua: 40000€ - 50000€
esperienza da 6 a 10 anniMin. 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 ( ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
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.