Regulatory Assistant at GlaxoSmithKline

Ref No: 140630-2
Location: Lagos
Reporting To: Regulatory Director

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:

        Phase 1 Labelling findings
        Phase 2 labelling findings
        Phase 1 CMC reviews
        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