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The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances,...
REQUIREMENTS
The External Evaluators are appointed in terms of section 3 (5) of the Medicine’s Act, as amended to assist the Authority in carrying out its functions. These fully qualified external evaluators are crucial to supplementing the skills and experience of the Authority in the area of Biological Medicines Evaluation. Expression of interest is required for experts who are already familiar with the ICH, SAHPRA and other recognised relevant international requirements for biological medicines as well as eCTD dossier reviews for both new biological medicines registrations and variations such that they are able to commence with immediate effect.
Expression of interest is required in the following disciplines:
Experience and knowledge in the following will be an added advantage:
EXCLUSIONS:
RELEVANT QUALIFICATIONS
TERM OF OFFICE
The term of service for external evaluators is three (3) years effective from date of appointment and may be appointed for a further extension of term(s).
Enquiries: Ms Mukona Mphidi at [email protected]
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