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, 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 (12 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.

• 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)
• 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.
• Expected placement in the Milan office with initial fixed-term contract (12 months)