Regulatory Assistant > Close Date: 2014/07/13
Job Title Regulatory Assistant
Location – Town / City Lagos
Location – Country Nigeria
Reporting To (Job Title) Regulatory Director
Type of position Contractor/Temporary
Job Purpose/Scope This is a 12 month fixed term contract to provide support to the Regulatory Affairs Department in implementing remediation activities across Anglophone West African (AWA) countries. The jobholder will have responsibility for:
•Variations collations, submission and tracking
•Tracking updated labelling from artwork change request approval to implementation in packs
•Updates handling
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
•Good Communication skills
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