Reporting To: 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

 

Regulatory Assistant

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

 

Method of Application

To apply, click here