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    Regulatory Affairs Consultant - London, United Kingdom - Lifelancer

    Lifelancer
    Lifelancer London, United Kingdom

    12 hours ago

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    Description

    Regulatory AffairsConsultant.

    • 8years experience in handling life cycle management of approved drugproducts (like tablets (oral solids) syrups (oral liquids)parenterals (injections/ injectables for EUmarket.
    • Good understanding of regulatoryframework including regional trends for various types ofapplications and procedures
    • Lead and / orcontribute to the planning preparation (including authoring whererelevant) and delivery of simple and with experience increasinglymore complex regulatory maintenance submissions from either aglobal and/or regional perspective.
    • Workingknowledge of EU/US regulatory procedures including post approvalrequirements. Knowledge of ROW markets regulatory legislationswould be an added advantage
    • Experience inhandling CMC related health authorityqueries
    • Good understanding of regulatoryframework including regional trends for various types ofapplications and procedures for small and large molecules acrossall regions as well as knowledge of global pharmaceuticallegislation and guidance specifically linked to regulatory CMCaspects in the ICH countries.
    • Liaise closelywith crossfunctional members with aligned productresponsibilities.
    • Develop execute and maintainsubmission delivery plans submission content plans and proactivelyprovide status updates to designatedstakeholders.
    • To prepare review and submitsafety variations to Health Authorities and also perform postApproval CMC related updates (whereapplicable).
    • Prior working experience inRegulatory Information Management Systems like Veeva Vault would bedesirable.
    • Strong communicationsskills
    • Ability to workindependently

    Please use the belowlink for job application and quickerresponse.

    RemoteWork :

    No

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