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.

Range RAL: 40000€ - 50000€

DUTIES & 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.

PROFESSIONAL EXPERIENCE REQUIREMENTS:

• 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
• 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)