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    Regulatory Affairs Manager - London, United Kingdom - Cpl Life Sciences

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    Description

    Job Title: Regulatory Affairs Manager (CTA/ CTR)

    Job Type: Permanent, full-time

    Locations: UK, Italy, Spain, Sweden or the Republic of Ireland – Remote based

    Remuneration: £50,000 to £65,000 + benefits

    Regulatory Affairs Manager opportunity working for a cutting edge Oncology focused global clinical research organisation conducting early- and late-phase oncology trials in the US, Europe, and Asia.

    In this role, you must be based in the UK, Italy, Spain, Ireland, or Sweden and will have the flexibility to be 100% remote. The position will be focused on Regulatory CTA/ CTR, amendments and end trial notifications for multiple projects and communicating effectively with clients according to business needs

    Role responsibilities

    • Provides strategic regulatory input to all assigned projects.
    • Management, preparation, assembly of the Master Core Dossier and submissions of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments
    • Country-level Informed Consent and other patient facing documentation
    • Tracks, reports and files CTAA and amendment submissions / approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
    • Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.


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