Regulatory Affairs Manager in Lagos, Nigeria

at GlaxoSmithKline

Manufacturing / Production
Manufacturing / Production
Minimum Qualification
Required Experience
5 - 7 years
Employment Type
Full Time
Male or Female

Job Description

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


  • 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

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