Posted on :
28 Nov, 2013
28 Nov, 2013
•To compile, and submit registration dossiers in accordance with the country specific requirements to relevant Regulatory Authorities in Southern Africa. Among others Angola and Mozambique
•Dossier Maintenance: Submission of post registration variations in line with country specific regulatory requirements
•Submission of updated product Package insert or labelling updates in line with the country specific requirements and in line with the internal GSK requirements
•To maintain the relevant Global, local Regulatory and compliance databases
Responsibility for 11 markets in Southern Africa (Angola, Botswana, Comoros, Namibia, Madagascar, Mauritius, Mozambique, Malawi, Seychelles, Zambia, Zimbabwe)
Evaluation, Compilation and submission of Registration Application dossiers to Southern African Regulatory Authorities, in accordance with established format.
Maintenance of registration dossiers including submission of renewals in the relevant markets
Submission of labelling updates in line with the GSK timelines and requirements and country specific requirements
Preparation of the copies of the dossiers prior to submission
Assist with the evalution of artwork and initiation of artwork changes where relevant
Liaising with the Regulatory Authorities in Southern Africa
Ensuring that the filing system and archiving is current and in order.
Competencies Job Factors:
Fluency in English
•Knowledge and experience of Regulatory Affairs in markets in Southern Africa will be an advantage
•Ability to prioritise and work on tight deadlines
•Detail orientated and organised
Challenging the constraints of Regulatory Authorities on regulatory issues
Handle communication with Regulatory Authorities with a view of minimizing negative impact for GSK.
Devise efficient filing strategies for a fast submission and approval turnaround time
Pay attention to details
Lobby and network with Regulatory Authorities for fast track approval of GSK products.
Provide regulatory support/training to stakeholders as appropriate
•Ability to work well under pressure and still maintain sound balance in decision making
Click here to apply online
Closing date: 2013/12/09