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    Regulatory Affairs Consultant - London, United Kingdom - Lifelancer Ltd

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    Description

    Regulatory Affairs Consultant Position at XYZ Pharmaceuticals

    • Over 8 years of experience managing life cycle of approved drug products such as tablets, syrups, and injectables for EU market
    • Deep understanding of regulatory framework and regional trends for various types of applications
    • Leading and participating in the planning and delivery of regulatory submissions on a global and/or regional scale
    • Familiarity with EU/US regulatory procedures and post-approval requirements
    • Experience in handling CMC-related health authority queries
    • Knowledge of global pharmaceutical legislation and guidance related to regulatory aspects in ICH countries
    • Collaborating closely with cross-functional team members
    • Developing and maintaining submission delivery plans
    • Preparing and submitting safety variations to Health Authorities
    • Familiarity with Regulatory Information Management Systems like Veeva Vault is a plus
    • Strong communication and ability to work independently


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