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Regulatory Affairs Executive - Oferta z Jobs.pl

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Regulatory Affairs Executive

Nr ref.: /JOBS.pl

  • Our client a global pharmaceutical company now have a requirement for a Regulatory Affairs Officer with experience in medical devices. Permanent role based in Dublin.

    The Job:

    • Ensure timely preparation and compilation of registration dossier components in accordance to EU or relevant Health Authority standards, and corporate requirements
    • Under supervision of the senior RA person (if required), manage international regulatory submissions according to company strategy and ensure registration deadlines are met
    • Responding to Health Authorities' queries and deficiencies in a timely manner
    • Liaise with other departments to support the timely introduction of new product into markets
    • Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner
    • Communication of Health Authority approvals/final decisions to the relevant departments
    • Build departmental awareness of local regulatory requirements in global markets
    • Compile regulatory components of annual product quality review (PQR)and PSUR/PBER
    • Archive the registration documentation according to internal standards; introduce and regularly update internal RA databases
    Perform assigned tasks with the highest quality and in accordance with established internal timelines and guidelines

    • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
    • Experience in a regulatory affairs environment required
    • Experience in the Medical Device/pharmaceutical industry
    • Working knowledge of current registration requirements for dossier preparation and procedure running an advantage
    • Solid knowledge of specific national requirements in usual target registration countries an advantage
    • IT tools utilised in RA department e.g. for Regulatory intelligence, eCTD, change control etc.

    For full details contact Tina at or email your CV to - For all vacancies log on to


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