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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Evaluation and assessment of the quality, safety and efficacy of new applications for the registration of Biological Medicines,
Evaluation and assessment of applications for the amendment of the quality, safety and efficacy aspects of registered Biological Medicines,
Evaluating applicant responses and variations for registrations and/or approval of medicines, Conducting Pre-Registration Consultation meeting for Biological Medicines,
Develop and update guidelines and/or SOPs as required, Participate in pre-registration consultations with manufacture.
Qualification :
Matric certificate and a relevant four-year Bachelor’s degree in Pharmacy, Biological Sciences, Biochemistry, or Microbiology from a recognized university or tertiary institution at NQF Level 8, as acknowledged by the South African Qualifications Authority (SAQA).
Alternatively, an Honours degree in a related health science at NQF Level 8, also recognized by SAQA, is acceptable.
For those with a Bachelor of Pharmacy (BPharm) degree, registration with the South African Pharmacy Council (SAPC) is mandatory, and proof of active registration as a Pharmacist must accompany the application.
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