Regulatory Affairs Manager

GlaxoSmithKline (GSK)

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GlaxoSmithKline (GSK), one of the world's leading research based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GSK employs over 97,000 employees in over 100 countries worldwide.

GlaxoSmithKline Consumer Nigeria Plc is one of Africa's largest consumer healthcare companies, producing leading brands such as Lucozade, Ribena and Panadol.

 

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

 

Basic Qualifications

  • Bachelor of Pharmacy degree/ BSc Biological Sciences
  • Preferred qualifications:
  • PharmD, PhD MBA, MSc, will be desirable

This job originally appeared elsewhere.

Summary

Company

GlaxoSmithKline (GSK)

Job Level

Manager (Staff Supervisor/Head of Department)

Location

Lagos

Specialization

Administration & Office Support

Job Type

Full-Time

Minimum Qualification

Degree

Preferred Years of Experience

5 - 7 years