Medicines Registration Officer: Clinical Post-registration

Requirements: 

Matric certificate and an appropriate four-year degree in Pharmacy at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) and registration with a Professional Body (South African Pharmacy Council) or an MBChB degree and registration as a Medical Officer with the Health Professions Council of South Africa (HPCSA). A relevant Masters degree in Health Sciences will be an added advantage. 

Experience: 

Grade 1 – A minimum of two (2) years of clinical experience post-internship and community service. Regulatory experience of at least one (1) year will be an added advantage. 

Grade 2 – A minimum of five (5) years of clinical experience post-internship and community service. Regulatory experience of at least one (1) year will be an added advantage. 

Competencies, Knowledge, and Skills: 

Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, concerning the regulation of medicines in terms of quality, safety, and efficacy. Knowledge and application of good review practices, SAHPRA guidelines, and other relevant international guidelines, e.g., ICH. Knowledge and understanding of the legal and regulatory framework governing the review process, locally and internationally. An understanding of the medicine’s discovery process and the pharmaceutical regulatory environment. Technical proficiency in regulatory review practices, pharmacokinetics, pharmacodynamics, bioavailability/bioequivalence, clinical study data analysis, and review for safety, efficacy, and quality.