Requirements: 

• Matric certificate and appropriate 4-year Degree in Pharmacy at NQF level 8 as recognised by SAQA and registration with a Professional Body (SAPC).
• A relevant Master’s Degree will be an added advantage.
• A valid driver’s license. 

Experience: 

• Grade 1 – A minimum of two (2) years of clinical experience post Internship and Community Service. Regulatory experience will be an added advantage.
• Grade 2 – A minimum of five (5) years of clinical experience post Internship and Community Service of which two (2) years should be within regulatory experience. 

Competencies, Knowledge, and Skills: 

Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. Good knowledge of the conduct of clinical trials. Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. Good planning, organizational and interpersonal skills. Self-motivated and able to work independently. Good communication skills (written, verbal, negotiation, conflict management, presentation). Innovative thinking, initiative, assertive and leadership qualities. Dedication and accurate work. Ethical behavior. Must be willing to travel and work irregular hours. Customer service. Planning and organizing skills. DUTIES: Technical review of clinical trial applications and provide recommendations for approval/rejection of clinical trial applications: Technical screening and review of new clinical trial applications to ensure adherence to SAHPRA requirements. Review applicant responses and recommend for approval or rejection of clinical trial applications. Communicate the recommendations queries, approval or non-approval to the Applicants. Manage submission of clinical trial application cycles. Technical Review of applications to conduct Bioequivalence studies and provide recommendations for approval/rejection of Bioequivalence studies. Technical screening and review of new Bioequivalence studies to ensure adherence to SAHPRA requirements. Provide recommendations on applications to Authority (Clinical Trials Expert Committee, if required). Review applicant responses and recommend for approval or rejection of Bioequivalence studies