Requirements:

Matric certificate and appropriate four-year degree in Pharmacy or relevant Natural Sciences at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA), and registration with a statutory council. A relevant Master’s degree will be an added advantage. A valid driver’s license. 

Grade 1 – A minimum of two (2) years of regulatory experience (post community service). Knowledge of the technical evaluation of the quality, safety and efficacy aspects of medicines. 

Grade 2 - A minimum of five (5) years of regulatory experience (post community service). Knowledge of the technical evaluation of the quality, safety and efficacy aspects of medicines. 

Competencies, Knowledge and Skills: 

Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. *Knowledge of the requirements for medicine Product Quality Reviews, the associated technical aspects of manufacturing and relevant Good Manufacturing Practices, as per SAHPRA GMP. *Knowledge of technical aspects for the evaluation of the quality and efficacy of bioequivalence of medicines. *Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. *Good planning, organisational and interpersonal skills. *Self-motivated and able to work independently. *Decision-making informed by technical expertise. *Good communication skills (written, verbal, negotiation, conflict management, presentation). *Innovative thinking, initiative, assertive and leadership qualities. *Dedication and accurate work. *Ability to manage a variety of cross-functional team members. *Ethical behaviour. *Computer skills (knowledge of MS Office). *Must be willing to travel and work irregular hours. *Customer service. 

Duties:

Evaluation and peer-reviewing of renewal applications: *Evaluate and generate evaluation report(s) for renewal applications (generics) in compliance with required template and adopted regulatory and scientific standards as per Good Manufacturing Practice (GMP) Pharmaceutical Inspection Co-operation Scheme (PIC/s) guidelines, European Medicines Agency (EMA) renewal guidelines, etc., and submit for peer review. *Peer review evaluation reports in compliance with good review practice and draft peer reviewed report. *Request Quality Assurance (QA), expert advice or send to technical committee meeting if necessary and submit signed report for filing and further processing. *Following peer review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates. *Prepare reports or memos for the internal working groups. *Prepare query letter to the applicant. *Provide QA of reports and facilitate resolutions on technical matters.

Evaluate applicant responses of renewal applications:

Evaluate and generate second (and subsequent) evaluation report(s) for each response application and submit for peer review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. *Peer review other evaluators’ response reports according to the required template and adopted regulatory/scientific standards. *Prepare reports and record outcomes for the internal working groups, technical meetings or committee meetings. *Prepare query letters to the applicants. *Provide QA reports and facilitate resolutions on technical matters.

Technical screening of renewal applications:

Generate technical screening evaluation report(s) for each application and submit for peer review. *Following the peer review process, amend the technical screening report(s) accordingly to generate a list of queries to the applicant using the correct templates. *Peer-review technical screening report(s) done by other reviewers. *Prepare screening query/screening rejection letter to the applicant. * Provide quality assurance of reports and facilitate resolutions on technical matters.

Develop and update guidelines, SOPs, and templates:

Review existing guidelines, Standard Operating Procedures (SOPs) and templates, and update when necessary. *Provide training on guidelines, SOPs, and templates. *Create new guidelines, SOPs, and templates where SOPs are not in place. *Provide regular work-plans and out put to the unit manager(qualitative and quantitative report). *Perform any other related duty as requested by the manager/senior manager.

Participate in technical working groups or special projects and provide support to the unit as well as to the Advisory Committees:

Participate in special projects as and when necessary based on the technical and operational needs of the unit. *Lead and manage assessments, peer review and discussion working groups where relevant. *Compile discussion documents and reports. *Take comprehensive notes of discussions of relevant discussions.

Risk Management and Audit:

SOPs and guidelines must be adhered to. *Create and maintain databases. *Use the most current templates and guidelines. *Provide and attend relevant training that may be necessary. * Align with Quality Management System (QMS) requirements. *Align with International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products(ICH/VICH), World Health Organisation (WHO) and international standards and use the most current SAHPRA templates and guidelines