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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Medicines Registration Officer:Biological Medicines ( Lot Release)
Evaluation and assessment of the quality, safety and efficacy of new applications for the registration 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 Biological medicines,
Develop and update guidelines and/or SOPs as required, Participate in pre-registration consultations with manufacture, Lot release functions for Vaccines...
Qualification :
Matric certificate and a relevant four-year Bachelor of Pharmacy, Biological Sciences, Biochemistry or Microbiology degree 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 a requirement with a BPharm degree.
A postgraduate qualification in relevant Science such as Biochemistry, Vaccinology, Pharmacology or equivalent and experience in biological medicines registration is an added advantage.
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