Regulatory Assistant in Lagos, Nigeria

at GlaxoSmithKline

Healthcare / Medical
Healthcare / Pharmaceutical
Minimum Qualification
Bachelor's Degree
Required Experience
3 - 5 years
Employment Type
Male or Female

Job Description

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 job holder will have responsibility for:

•Variations collations, submission and tracking
•Tracking updated labeling 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 Labeling findings
o Phase 2 labeling findings
o Phase 1 CMC reviews
o Phase 2 CMC reviews

•Work with concerned sites to drive timely implementation of updated labeling information in commercial packs as per agreed implementation time frame from Agile/Manual artwork approval closure date

•Provide support to the department to 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



•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

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