Contractor Regulatory Operations Associate

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, who will be in charge of for?regulatory change management/renewal/query?activities?for products manufactured by?External Supply Quality?(ESQ) managed?contractors.
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 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.