Contractor Regulatory Operations Associate

2 settimane fa


Milano, 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.
Placement expected at the Milan office with initial fixed-term contract (6 months) with possibility of extension.
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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