• Vacancy at GlaxoSmithKline

  • Posted on: 1 July, 2014 Deadline: Not Specified
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  • Reporting To: Regulatory Director
    Type of position: Contractor/Temporary

    Job Purpose/Scope
    This is a 12 month fixed term contract to provide support to the Regulatory Affairs Department in implementing remediation activities across Anglophone West African (AWA) countries. The jobholder will have responsibility for:

    • Variations collations, submission and tracking
    • Tracking updated labelling from artwork change request approval to implementation in packs
    • Updates handling

    Regulatory Assistant

     

    Key Responsibilities    
    • Work with the Central Project Team and Head of Department on agreed remediation action plan to close all findings for concerned AWA countries as it relates to:
    o Phase 1 Labelling findings
    o Phase 2 labelling findings
    o Phase 1 CMC reviews
    o Phase 2 CMC reviews
    • Work with concerned sites to drive timely implementation of updated labelling information in commercial packs as per agreed implementation time frame from Agile/Manual artwork approval closure date
    • Provide support to the department o achieve 100% Regulatory Governance all year round in AWA as it relates to project related activities
    • Work in line with company policies and processes

    Qualifications, Experience    
    • First degree in a Biological Sciences or Quality related courses
    • Minimum of 3 years working experience in the industry/similar role

    Competencies    
    • Sound understanding of basic Regulatory guidelines both locally and internationally
    • Knowledge of Quality Management System principles and guidelines as it relates to marketing companies in GSK
    • Ability to plan and organise work
    • Use regulatory knowledge to ensure fast product approvals
    • IT proficiency

    Method of Application

    To apply, click here

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