Randstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Operations Associate. The selected candidate will be responsible for regulatory change management, renewal and query activities for products manufactured by External Supply Quality (ESQ) managed contractors. This position is based at the Milan office and is offered as a fixed‑term contract of 12 months, with the possibility of extension.
DUTIES & RESPONSIBILITIES
- Initiate, review and approve regulatory changes through the 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.
- Act as the main point of contact for the GlobalChemistry Manufacturing & Controls (GCMC) department and local regulatory affairs in Pfizer country offices (single‑market products) for regulatory activities involving ESOQ contractors.
- Participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESQ managed contractors and, if needed, attend site quality visits at the contractors.
PROFESSIONAL EXPERIENCE & REQUIREMENTS
- Minimum Bachelor’s degree in Science, Engineering, Pharmaceutical Sciences, Regulatory or a related technical discipline.
- Minimum 2 years of experience in a GXP setting and/or regulatory affairs role (or 1 year with a master’s degree).
- Good verbal and written communication skills, including presentation skills.
- Advanced computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms.
- Good command of English; multilingual ability is a vantaggi.
- Strong negotiation skills and customer focus; diplomatic communication with internal and external customers.
- Ability to work in a diverse, multi‑level, cross‑divisional, and multicultural environment and to report remotely while delivering work independently.
Regulatory Operations Associate • Milano, IT
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