MEDICINES REGISTRATION OFFICER: PRE-REGISTRATION (PHARMACEUTICAL EVALUATION MANAGEMENT) (REF: SAHPRA 23 OF 2026/27)

Matric certificate and appropriate four-year Bachelor of Pharmacy degree (NQF Level 8) or an Honours degree in related health sciences as recognised by the South African Qualification Authority (SAQA) * Registration with the South African Pharmacy Council (SAPC) * A relevant master’s degree qualification at NQF Level 9 as recognised by SAQA will be an added advantage. Planning and organisational skills... Co-ordination skills... Written and verbal communication skills... Time management... Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations and guidelines... Technical and scientific aspects of medicine regulation... Evaluation guidelines as prescribed by the relevant regulatory authorities... Knowledge of the technical aspects for the evaluation of the quality and efficacy (bioequivalence) of medicines... Computer literacy and a sound working knowledge of computer software packages...

Evaluation of new applications and peer reviewing of new applications. Generate evaluation report(s) for each new application (new chemical entities (NCE) and Generics) in compliance with required template and adopted regulatory/scientific standards and submit for peer review. Prepare query letters to applicants. Prepare a basis of approval or rejection. Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. Evaluate applicant responses for registration/approval of medicines. Following the peer-review process, amend the report accordingly to generate a list of queries to the applicant, if necessary. Peer review other evaluators’ response reports, according to the required template and adopted regulatory/scientific standards. Review existing guidelines, standard operating procedures (SOPs) and templates and update when necessary. Prepare and submit regular work plans and qualitative and quantitative performance reports to the manager. Member of technical working groups or special projects and provide support to the Business Unit as well as to advisory committees. Participate in special projects and medicines registration groups...

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