Medicine Registration Officer: Clinical Pre-registration Evaluations at South African Health Products Regulatory Authority

REQUIREMENTS: 

• Matric certificate and appropriate 4-year Degree in Pharmacy or related qualification at NQF level 8 as recognised by SAQA and registration with a Professional Body. 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. 

DUTIES:

• Evaluation of new applications and peer-reviewing of new applications: Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letter to the applicant. 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 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 report for the internal working groups and where necessary present at advisory committee for complex scientific matters. Prepare query letter to the applicant. Prepare a basis of 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 report(s) for each application. 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, SOPs and templates and update when necessary. Provide training on guidelines, SOPs, and templates. Create new guidelines, SOPs, and templates where SOPs aren’t in place. 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. 
• Form part of technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: Participate in special projects and registration group. Lead and manage assessments peer review and discussion working group where relevant. Compile discussion documents and reports. Provide regular trainings to new internal MRO’s and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for SAHPRA management/ RC meeting. 
• Audit and Risk Management: SOP’s and Guidelines must be adhered to. Create and maintain data bases. Use the most current templates and guidelines. Provide and attend relevant training as may be necessary. Align with QMS requirements. Align with ICH, WHO and international standards.