• Career Opportunity at GlaxoSmithKline plc (GSK)

  • Posted on: 10 October, 2016 Deadline: Not Specified
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  • GlaxoSmithKline plc (GSK) is a British multinational pharmaceutical, biologics, vaccines and consumer healthcare company which has its headquarters in Brentford, London. As of March 2014, it was the world's sixth-largest pharmaceutical company after Johnson & Johnson, Novartis, Hoffmann-La Roche, Pfizer, and Sanofi, measured by 2013 revenue. The company was established in 2000 by the merger of Glaxo Wellcome (formed from the acquisition of Wellcome plc by Glaxo plc) and SmithKline Beecham plc (formed from the merger of Beecham Group plc and SmithKline Beckman Corporation, which in turn was formed by combining the Smith, Kline & French and Beckman companies).

    Regulatory Affairs Manager

     

     Requisition ID: WD91860

    Basic qualifications:

    Bachelor of Pharmacy degree/ BSc Biological Sciences

    Preferred qualifications:
    PharmD, PhD  MBA, MSc, will be desirable

    Details:

    JOB PURPOSE
    To support the Head of Regulatory  in the implementation of  agreed regulatory strategy  as it relates to  registered products life cycle maintenance and  NCEs/NPDs and Branded generics registration in the market
    Work with the RAD to simplify and improve existing regulatory processes, systems and techniques to enhance capability of Regulatory Executives

    KEY RESPONSIBILITIES:

    • Regulatory Due Diligence for successful NCEs/NPDs/PREPs registration
    • Clinical Trials Submissions and Tracking with Regulatory Agencies
    • OPAL Champion for (maintains updates and correctness of all approved  products  databases and Variations)
    • Supervision of the REs to ensure deliverables are met yearly
    • Agile MLCC for all products
    • IPI and PSUR updates handling
    • Registered products Regulatory Databases maintenance /compliance
    • Support the RAD in Regulatory Governance/Conformance Activities. E.g Project Edge Labelling
    • Provide regulatory support as and when required for special projects
    • Interphase with the Africa Regulatory Hub team on life cycle management processes
    • External facing with Regulatory Agencies as back up for the Regulatory Affairs Director

    Important notice to Employment businesses/ Agencies
    GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Method of Application

    Interested and qualified? Go to GlaxoSmithKline career website on careers.peopleclick.com to apply

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