Regulatory Operations Specialist
4 settimane fa
Randstad Italia spa is seeking a highly skilled Contractor 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 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 GlobalChemistry Manufacturing&Controls (GCMC) department or Local Regulatory Affairs in Pfizer Country Offices for regulatory activities involving ESOQ contractors.
- Participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and site quality visits at contractors as needed.
- 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 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.
This is a fixed-term contract position with an expected placement in the Rome office. We are an equal opportunities employer and welcome applications from both men and women (L.903/77).
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