Medicine Registration Officer: Clinical Preregistration Evaluation at South African Health Products Regulatory Authority

REQUIREMENTS: 

• Matric certificate and appropriate 4-year Degree in Pharmacy at NQF level 8 as recognised by SAQA and registration as a Pharmacist with a Professional Body (SAPC) or 4-year science degree in a health science related field at NQF level 8 as recognised by SAQA from a recognized university or tertiary institution. A valid driver’s license.  

EXPERIENCE:

• At least one-year regulatory experience (post community service). 

DUTIES:

• Evaluation of new applications and peer-reviewing of new applications/variations: Generate evaluation reports for each new application and submit for peer review in compliance with required template and adopted regulatory /scientific standards (depend on the type of application, i.e., Full/partial reviews Q-BE and Reliance. Evaluation of Type I and II clinical/quality variation applications. Following peer review process, amend the report accordingly to generate a list of queries to the applicant using the correct templates (Full/partial reviews Q-BE and reliance). Peer review other evaluators reports according to the required template and adopted regulatory /scientific standards (Full/partial reviews Q-BE and reliance). Evaluation of PI/PIL applications (new applications and responses). Prepare query or approval or rejection letter to the applicant.
•  Evaluate applicant responses for registration/approval of medicines: Generate second (and subsequent) evaluation report (s) for each response application review. Following 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. 
• Develop and update guidelines, SOPs, and templates: Review existing guidelines, SOPs and templates and update when necessary and provide and attend trainings on guidelines, SOPs and template to new MROs and external evaluators. Create new guidelines, SOPs, and templates where relevant. 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: Prepare report for the internal working groups and/or advisory committee and where necessary present at advisory committee for complex scientific matters and ensure adherence to SOPs and Guidelines. Provide quality assurance of reports and facilitate resolutions on technical matters. Align with ICH, WHO, IPRP, international standards, SAHPRA QMS requirements and use the most current SAHPRA templates and guidelines. Timeous execution of recommendations from the advisory committee. 
• Provide technical advice and information to all stakeholders (internally and externally): Attend to queries from various stakeholders. Provide technical advice and information to all stakeholders. Attend to queries from the Manager, Senior Manager, other Programmes, the legal unit and the Chief Regulatory Officer’s office. 
• Technical screening of applications for the registration of medicines: Generate technical screening evaluation report(s) for each application and submit for peer review. Following 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.