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Contractor Regulatory Operations Associate

https://www.randstad.com Logo

Randstad

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Location:
Italy , Milano

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Category:
-

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Contract Type:
Not provided

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Salary:

40000.00 - 50000.00 EUR / Year

Job Description:

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, will be in charge of for regulatory change management/renewal/query activities for products manufactured by External Supply Quality (ESQ) managed contractors. Placement expected at the Milan office with initial fixed-term contract (12 months) with possibility of extension.

Job Responsibility:

  • 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 the 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) dpt or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors
  • As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESQ managed contractors and if needed, participate in Site Quality visits at the contractors

Requirements:

  • 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 years with Masters degree)
  • Good verbal & written skills
  • 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 English language
  • Strong verbal and written communication skills including presentation skills
  • Able to work in 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
  • Is diplomatic in communication with internal and external customers

Nice to have:

multi-lingual is a benefit

Additional Information:

Job Posted:
May 12, 2026

Expiration:
June 22, 2026

Work Type:
On-site work
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