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.
responsabilità
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.
esperienza
2 anni
competenze
Qualifications
Min. BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical discipline
Min. 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 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
Fluent 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
Expected placement in the Rome office with a fixed-term contract.
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livello di studio
Diploma di laurea (3 anni) o ITS (2-3 anni)