Regulatory Affairs Manager at GlaxoSmithKline

 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

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