Purpose:
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 requirements
To maintain the relevant Global, local Regulatory and compliance databases

Responsibilities
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 timelines and requirements and country specific requirements
Preparation of the copies of the dossiers prior to submission
Assist with the evaluation 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.
Responsibility for 11 markets in Southern Africa (Angola, Botswana, Comoros, Namibia, Madagascar, Mauritius, Mozambique, Malawi, Seychelles, Zambia, Zimbabwe)

Qualifications, Experience
Matric
Pharmacy Assistant Diploma/BA in related field/Science related degree/
1- 2 years’ experience in a pharmaceutical regulatory environment
Knowledge and experience of Regulatory Affairs in markets in SA