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Regulatory Operations Associate

2 mesi fa

Roma, Lazio, Italia Randstad A tempo pieno
Regulatory Operations Associate

Randstad Inhouse Services, a leading provider of specialized staffing solutions, is seeking a highly skilled Regulatory Operations Associate to join our team in Rome. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and managing regulatory change management activities for products manufactured by External Supply Quality (ESQ) managed contractors.

Key Responsibilities:
  • Initiate, review, and approve regulatory changes through Pfizer's 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) or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for regulatory activities involving ESOQ contractors.
  • Participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and, if needed, participate in Site Quality visits.
Requirements:
  • 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).
  • Good verbal and written skills.
  • Advanced computer skills, including MS Office applications and 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 a 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.
  • Diplomatic in communication with internal and external customers.

This is a fixed-term contract opportunity with Randstad Inhouse Services. If you are a motivated and detail-oriented professional with a passion for regulatory operations, we encourage you to apply.