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  • Posted: Sep 7, 2017
    Deadline: Not specified
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    Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.
    Read more about this company

     

    RA Associate

    Job ID: 222009BR
    Location: Lagos
    Division: SANDOZ
    Business Unit: Commercial Ops SZ
    Functional Area: Research & Development

    Job Description    

    • New Product Registrations: Prepares and submits documentation for application of drug registration in a timely manner and monitoring of the application during the evaluation phase to achieve a favourable outcome within agreed timeframes
    • Maintenance of registered products: Support the DRA Manager, Sandoz in maintaining registration of currently approved products and timely submission of documentation for renewal of registration.
    • Prepares, submits and monitors variation packages to the health authority and ensures timely approval
    • Prepares & submits CDS update and PSUR to the health authority and ensures safety update is implemented if required
    • Prepares text master and final artwork master in accordance with local labelling regulations and Sandoz internal requirement
    • Ensures the implementation of Company corporate Quality Standards in the RO to be compliant with Novartis Quality standards/Sandoz Standards.
    • Ensures full QA support for all QA related activities.
    • Assist in ensuring that all aspects of the handling and distribution of pharmaceutical products at the site/in the country and all other QA related activities comply with the requirements of the Novartis Quality Manuals (QM), Sandoz GOPs and internal company SOPs
    • Ensures implementation of relevant Sandoz d.d. SOP to the RO organisation
    • Ensures that compliance is maintained for Quality System and all Standard Operating procedures (SOPs) are in place for all GXP related activities
    • Assists in ensuring adequate escalation process up to the management according to escalation management
    • Maintains knowledge of local and international regulatory and legislative requirements and trends to ensure technical support on all quality related aspects to the RO
    • Ensures all product specific annexes and QA agreement with each sites are updated and approved
    • Assists in ensuring that all activities related to complaints, market action/recalls are performed in accordance with the relevant QM and are in compliance with the local regulations and Sandoz standards
    • In case of any local third party coordination of the following activities with Sandoz d.d. responsible person: Audit and Quality Agreements with 3rd parties. Ensures coordination of third party activities (re-packaging, re-labelling , storage and/or distribution in way that all activities on 3rd party site are in compliance with Sandoz standards

    Minimum Requirements    

    • Bachelors Degree in Pharmacy English 2 - 5 years experience in Regulatory Affairs or a similar role

    Method of Application

    Interested and qualified? Go to Novartis International AG on sjobs.brassring.com to apply

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