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,...
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Manage the operations of the Biological Medicines Unit concerning the processes, inputs, targets, outputs, and resourcing requirements to ensure effective operation within the unit,
Manage the development of regulations, regulatory processes, and guidelines within the Biological Medicines Unit to ensure efficiency, considering best practice and guidelines, Compilation of statistics of the Unit to compile reports for monthly, quarterly, and annual presentations,
Supervision of assessment and authorisation of registered and new registration applications of Biological Medicines, Management of evaluation and assessment of registration and amendments of biological medicines,
Overseeing of vaccines and biological medicines’ Lot Release, Responsiveness to external inquiries by industry and other departments in SAHPRA and other external stakeholders...
Qualification :
Matric certificate and appropriate four-year Bachelor’s degree in Pharmacy, Biological Sciences, Biochemistry, or Microbiology from a recognised university or tertiary institution at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA),
or an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA. Registration with the South African Pharmacy Council (SAPC) is required for applicants with a BPharm degree,
A postgraduate qualification in a relevant science such as Biochemistry, Vaccinology, Pharmacology, or equivalent, and experience in biological medicines registration will be an added advantage.
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