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    Senior Compliance Consultant - London, United Kingdom - Clinical Professionals Limited

    Clinical Professionals Limited
    Clinical Professionals Limited London, United Kingdom

    1 week ago

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    Description
    Senior Regulatory Affairs Labelling Consultant

    Job Type:
    Permanent

    Job Title:
    Senior Regulatory Labelling Consultant (Labelling Strategy)

    Location:
    UK and Europe – Fully Remote

    Salary:
    Competitive Salary + Excellent Benefits


    Employee Type:
    Permanent

    You will work as a regulatory affairs labelling lead for developing and establishing drug programs and be accountable for driving global labelling strategy.

    This is a challenging opportunity to demonstrate your knowledge in managing regulatory processes and supporting cross-functional teams with labelling compliance.

    This role can be based in the UK or Europe and offers the right candidate a chance to take the lead on regulatory labelling processes.

    Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.


    • Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed.
    • Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
    • Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.

    Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (EU SmPC, EU PIL, etc) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.


    • Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation.
    • Support labeling inspection / audit readiness activities
    University Degree in a scientific degree
    ~4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
    ~ Regulatory Information Management System (RIMS), electronic document management system (EDMS). In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams
    ~ Fluent in English written and spoken
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