Regulatory Operations Specialist
3 settimane fa
Job Title: Contractor Regulatory Operations Associate
About the Role:
Pfizer srl is seeking a skilled Contractor Regulatory Operations Associate to join their regulatory team. The ideal candidate will be responsible for regulatory change management, renewal, and query activities for products manufactured by External Supply Quality (ESQ) managed contractors.
Main Responsibilities:
Initiate, review, and approve regulatory changes through Pfizer enterprise system for changes initiated by or impacting ESQ managed contractors.
Provide support for the closure of deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations, and Post approval variations.
Act as the main point of contact for Global Chemistry Manufacturing Controls (GCMC) department or Local Regulatory Affairs in Pfizer Country Offices for the regulatory activities involving the ESQ contractors.
Participate as the Regulatory Expert in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors, and if needed, participate in Site Quality visits at the contractors.
Requirements:
Bachelor's degree in Science, Engineering, Pharmaceutical Sciences, Regulatory, or related technical discipline.
At least 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 in computer skills such as MS Office applications, and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms.
Strong command of English language, multilingual is a benefit.
Able to work in diverse multi-level, cross-divisional, and multi-cultural working environment, able to report remotely and deliver work independently.
Able to negotiate and communicate diplomatically with internal and external customers.
About Randstad Italia Spa:
Randstad Italia Spa is a leading recruitment agency that provides staffing solutions for various industries. We are committed to helping our clients find the best talent and providing our candidates with excellent career opportunities.
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