Requirements

Applicants must be in possession of a Matric certificate and appropriate four-year Bachelor of Pharmacy degree and registration as a pharmacist with the South African Pharmacy Council (SAPC) 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. A relevant master’s qualification at NQF Level 9 as recognised by SAQA will be an added advantage. Valid driver’s license. 

Experience 

Grade 1: 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) plus a minimum of three (3) years’ experience (post community service) in a Regulatory, Quality Assurance or Production environment; OR Honours Degree in related health Sciences at NQF level 8 as recognised by SAQA plus a minimum of five (5) years’ experience in a Regulatory, Quality Assurance or Production environment. 

Grade 2: 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with South African Pharmacy Council (SAPC) plus a minimum of five (5) years’ experience (post community service) in a Regulatory, Quality Assurance or Production environment; OR Honours Degree in related health Sciences at NQF level 8 as recognised by SAQA plus a minimum of eight (8) years’ experience in a Regulatory, Quality Assurance or Production environment. 

Competencies, Knowledge and Skills 

Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures and work instructions. Performance measurement skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Competent in problem solving and team building. Information evaluation. Decision making. Objectivity. Resilience. Communication skills (verbal, written, negotiation, conflict management, presentation). Interpersonal skills. Assertiveness. Ethical behaviour. Customer service. Planning and organising skills. Team management. 

Duties: 

Evaluation of quality variations for small molecule product applications and peer-reviewing of these applications. Write reports and draft query and approval/rejection letters after evaluation: Evaluation of Type I and II quality variation applications in accordance with EMA variation guidelines, ICH requirements and minimal international standards. Prepare a detailed scientific evaluation report in accordance with the Good Review Practice guide and competency assessment rubric. Peer-review reports done by other reviewers in accordance with the Good Review Practice guide and competency assessment rubric. Do a QA check or technical discussion on evaluation reports, in cases where this is needed. Prepare report for the internal peer review or technical discussion meetings and where necessary present at advisory committee. Prepare draft query, approval or rejection letter to the applicant, whichever is relevant. Check letters for correctness for technical requirements and for spelling, grammar and sentence construction. 

Technical screen and evaluate the quality and efficacy (Bio-equivalence) aspects of the quality variation applications for the registered medicines: Complete technical screening of all new variations received in accordance with technical screening SOP and record on the tracker. Generate screening/evaluation query letter for relevant technical queries. Complete technical screening, check on the validation template and draft templates for evaluators, and save these on the shared drive in the application specific folder. Complete admin screening and verify fees, by calculating required fees. Record the fees paid as per the POP in the dossier, in the tracker and communicate shortfalls via unit email. Create POP folder on the shared drive for each new sequence and save POPs. Update the tracker with the above information and the payments which were made in response to queries sent to the applicant. 

Evaluate applicant responses and variations for the registered medicines: Evaluate the quality and efficacy (Bio-equivalence) aspects of responses to queries on the variations to registered products, in line with Good Review Practice guide, ICH guidelines, EMA guidelines and other relevant international standards. Generate detailed scientific evaluation reports in line with the Good Review Practice guide, ICH guidelines, EMA guidelines and other relevant international standards. Prepare report for the internal peer review and where necessary present at advisory committee. Prepare approval/query/rejection letter as applicable. 

Form part of technical working groups or special projects and also provide support to the Advisory Committees: Participate in special projects and Pre and Post registration working groups as required and engage in technical scientific discussions on ongoing applications under review. Lead and manage (including organising) assessments peer review and discussion working groups, where relevant, and do research if necessary to contribute to the discussions. Compile discussion documents, including agendas, minutes and actions items, and reports. Update these regularly as necessary. Record meetings and save in the unit shared drive. Take comprehensive notes of discussions of relevant discussions in meetings and update documents regularly. Implement any scientific decisions in future assessments. Participate in international scientific regulatory forums and discussion groups including ICH, IPRP and WHO, as relevant and when nominated. 

Risk Management and Audit: SOPs and SAHPRA, ICH, EMA and other relevant guidelines must be adhered to. Create and maintain data bases as needed. Respond to relevant queries timeously. Respond to applicants’ questions pertaining to recommendations and any other related concerns. Attend relevant training as may be necessary and give feedback to the unit after attendance. Provide training and mentorship for other staff members if relevant - this includes technical scientific trainings as well as practical administrative trainings. Keep updated on regulatory updates and latest scientific discussions and alerts with regards to medicines quality, safety and efficacy. 

Develop and update guidelines, SOPs and templates: Review existing SOPs and update when necessary. Provide comments and corrections to SOPs which are currently under review. Create new SOPs where relevant or as instructed by the manager. Provide regular work-plans and output to the unit manager (qualitative and quantities report). Perform any other related duty as requested by manager/senior manager.