Social network you want to login/join with: Contractor Regulatory Operations Associate (Fixed Term Contract), Roma

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4 Posted:

10.03.2025 Expiry Date:

24.04.2025 Job Description:

Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer Srl to join the regulatory team. The resource will be in charge of regulatory change management, renewal, and query activities for products manufactured by External Supply Quality (ESQ) managed contractors, as a

Contractor Regulatory Operations Associate . Is Offered:

Initial fixed-term contract of 9 months. Annual salary:



€34,000 - €40,000, commensurate with experience, in accordance with the chemical collective bargaining agreement. What Will You Be Responsible For?

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 deficiency letters, CMC Commitments, regulatory requests for renewals, new product registrations and post-approval variations; Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) department or Local Regulatory Affairs in Pfizer Country Offices (single market products) for the regulatory activities involving the ESOQ contractors; As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and if needed, participate in Site Quality visits at the contractors. What Requirements Are We Looking For?

Minimum BA/BS in Science, Engineering, Pharmaceutical Sciences, Regulatory or related technical discipline; Minimum 2 years of experience in GXP setting and/or Regulatory Affairs role (or 1 year with Master’s 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 the English language; 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 environments; Ability to report remotely and deliver work independently; Demonstrates strong negotiation skills and customer focus; Diplomatic communication style with both internal and external customers.

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