Career Opportunity at GlaxoSmithKline plc (GSK)

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).

Position: Regulatory Affairs Manager

Requisition ID: WD91860
Position: Full time
Open date: 10-Oct-2016 14:35:33
Functional area: Regulatory
Location: Lagos, Nigeria-Lagos
Required degrees: Bachelors
Relocation: Not Indicated

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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