Contractor Regulatory Operations Associate

2 mesi fa


Milan, Italia Randstad A tempo pieno

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. 

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

 



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