Regulatory Assistant at GlaxoSmithKline

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