11 Oct 2016

Full-Time Careers at GlaxoSmithKline plc (GSK)

Toni AdewunmiAnywhere

Job Description

Regulatory Affairs Manager

  • Location Lagos

Requisition ID: WD91860

Basic qualifications:

Bachelor of Pharmacy degree/ BSc Biological Sciences

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


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

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.

Job Categories: Manager Jobs in Nigeria. Job Types: Full-Time. Job expires in Endless.

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