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Regulatory Affairs Specialist

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CareerWise Recruitment
📍 Cork, Ireland
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Location Cork
📅
Posted June 15, 2026
🚗
Commute Local Area
🎯
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Job Description

Job Description

Regulatory Affairs Officer
Our client who is a leading pharmaceutical company baesd in Waterford is looking for a Regulatory Affairs Specialist for a 9-month contract. If you have experience in regulatory affairs in the pharmaceutical or biopharmaceutical industry then this is the job for you !! This is a hybrid position with 3 days on site and 2 days working from home


The Role


  • Maintenance of, and variations to, CMC Dossier for assigned products.
  • Support and manage all regulatory requests impacting site products including coordination of site expert responses to support GRA in conclusion of request for information (RFI) activities as a result of deficiency letters (DLs) received from respective Health Authorities (HAs).
  • Assess the regulatory impact of proposed changes by site for assigned products.
  • Review and approval of Quality documentation including (but not limited to): batc...

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    📍 Location Details

    🌆
    City
    Cork
    🗺️
    Country
    Ireland
    🚗
    Commute
    Local Area

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