Medicines Registration Officer: Pre-Registration (Pharmaceutical Evaluation Management) at South African Health Products Regulatory Authority

REQUIREMENTS:

• Applicants must have a Matric certificate and an 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 licence required. 

EXPERIENCE
Grade 1: 

• Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of three (3) years’ regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance; 
• OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of five (5) years’ regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 

Grade 2: 

• Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of five (5) years’ regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance
•  OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of eight (8) years regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 

DUTIES: 

• 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. Following the peer-review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates. Peer review primary report(s) compiled by other reviewers. Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. Prepare query letters to applicants. Prepare a basis of approval or rejection. Provide quality assurance of reports and facilitate resolutions on technical matters. 
• Evaluate applicant responses for registration/approval of medicines: Generate second (and subsequent) evaluation reports for each response application and submit for peer-review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. 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. Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. Prepare query letters to applicants. Prepare a basis for approval or rejection. Provide quality assurance of reports and facilitate resolutions on technical matters. 
• Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: Generate technical screening evaluation reports for each application and submit for peer-review. Following the peer-review process, amend the technical screening reports accordingly to generate a list of queries to the applicant using the correct templates. Peer-review technical screening reports compiled by other reviewers. Prepare screening query/screening rejection letters to applicants. 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 relevant. Provide regular work plans and output to the unit manager (qualitative and quantitative reports). Perform any other related duty as requested by the manager/senior manager. 
• Form part of technical working groups or special projects and provide support to the unit as well as to advisory committees: Participate in special projects and registration groups. Lead and manage assessments, peer review and discussion working groups, where relevant. Compile discussion documents and reports. Provide regular training to new internal medicine registration officers (MROs) and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for the SAHPRA management/RC meetings. 
• Risk Management and Audit: Adhere to SOPs and guidelines. Create and maintain databases. Use the most current templates and guidelines. Provide and attend relevant training as may be necessary. Align with Quality Management System requirements. Align with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, World Health Organisation, International Pharmaceutical Regulators Programme and other international standards.