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Regulatory Affairs Officer Submissions - Oferta z Jobs.pl

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Regulatory Affairs Officer Submissions

Nr ref.: /JOBS.pl

  • On behalf of our client, a growing pharmaceutical company, we are currently recruiting for Regulatory Affairs Officers for submissions. These are for permanent opportunities.

    • Assessment of the content and format of RA documents vs. registration requirements and guidelines.
    • Coordination & preparation of regulatory submissions
    • Negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
    • Foster good working relationships with relevant regulatory bodies.
    • Ensure that timely responses to the regulatory queries raised during the evaluation process
    • Ensure all activities are within the framework of the Quality system, including the setting and achievement of relevant KPIs.

    • A minimum of relevant Life Science degree and/or a minimum of 1 years EU Submissions experience.
    • Working knowledge of EU regulatory requirements and procedures required. This includes good understanding of CMC and eCTD requirements.
    • Solid knowledge of IT tools specific for in RA and pharmaceutical sector (as eCTD, databases, change control management etc.) required.
    • Experience of working in accordance with quality standards e.g. GMP
    • Strong team member with the ability to identify and drive quality improvements
    • Good administrative/organisational ability with attention to detail is required.
    • Be able to work autonomously and have good problem solving skills.

    For more information and to apply for this role please call Linda on 1 or e-mail

    Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1


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