contractor regulatory operations associate.

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. 

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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