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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 ...
Key Responsibilities
• Work with the Central Project Team and Head of Department on agreed remediation action plan to close all findings for concerned AWA countries as it relates to:
o Phase 1 Labelling findings
o Phase 2 labelling findings
o Phase 1 CMC reviews
o Phase 2 CMC reviews
• Work with concerned sites to drive timely implementation of updated labelling information in commercial packs as per agreed implementation time frame from Agile/Manual artwork approval closure date
• Provide support to the department o achieve 100% Regulatory Governance all year round in AWA as it relates to project related activities
• Work in line with company policies and processes
Qualifications, Experience
• First degree in a Biological Sciences or Quality related courses
• Minimum of 3 years working experience in the industry/similar role
Competencies
• Sound understanding of basic Regulatory guidelines both locally and internationally
• Knowledge of Quality Management System principles and guidelines as it relates to marketing companies in GSK
• Ability to plan and organise work
• Use regulatory knowledge to ensure fast product approvals
• IT proficiency
To apply, click here
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