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Latest Job Vacancy At GlaxoSmithKline Plc

Date Posted: 30/Jun/2014
Deadline: 13/Jul/2014

Regulatory Assistant

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

 

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Method of Application

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