Job Vacancies at South African Health Products Regulatory Authority

REQUIREMENTS:

• Matric certificate and appropriate Science Degree with Honours at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA), OR a 4-year degree in Health Science at NQF Level 8, as recognised by SAQA, and registration with a statutory council if applicable. Certificate in Project Management will be an added advantage. 

EXPERIENCE:

• A minimum of five (5) years of relevant work experience with 3 years’ experience in a regulatory environment. Management experience as well as experience in the Medicines Regulatory environment, and Risk and Software management will be an added advantage. Valid driver’s license. 

DUTIES:  

Operational Management: 

• Manage the application receipt and preliminary review to verify that applications are compliant to SAHPRA’s requirements and determine whether the applications may advance to the review phase: Verify and ensure that submitted applications are received and recorded on the relevant trackers/databases and medicines register. Verify and ensure that technical screening of applications and responses is performed in accordance with the validation, screening templates or checklists, timeously and according to the units work plan and submission schedules. Quality check and approve admin and technical screening in accordance with the validation template or checklist and upload to the file plan. Ensure that status information is captured on the tracker/ database by the relevant screeners.
• Manage/the allocation, recording and monitoring of applications: Compile and maintain a list of the expertise of evaluators. Ensure that the tracker is updated routinely by the relevant evaluator coordinator for traceability and transparency of applications. Ensure that the applications are allocated based on the level of expertise and availability of evaluators. Monitor applications in progress to ensure timeous interventions and develop contingency plans for potential problems where applicable.Conduct quality control checks on the evaluation reports and queries/approval letters and ensure they are uploaded on the file plan. Conduct quality checks on applicable documents and ensure the database records are updated accordingly.   

 Financial Management: 

• Oversee the claims and revenue process: Verify claims received are recorded and submitted to finance timeously. Check for correct claim codes on claim forms submitted by evaluators to ensure that the evaluators are paid correctly and that the units expenditure is managed appropriately. Verify collation of revenue information for received applications. Fosters an environment where cost-benefit outcomes are continuously improved by checking that POE’s are compiled correctly. 
• Governance, Risk and Compliance: Check for compliance and ensure reports/letters are completed on the latest QMS controlled version of the evaluation letters/ templates. Conduct self-inspections of work practices, record deviations to ensure adherence to standard operating procedures and SAHPRA guidelines. Develop, maintain and distribute SOPs and templates. Develop work plans and/or programmes to implement provided strategic direction.Support unit with QMS internal and external audits including ISO 9001:2015 certification by responding swiftly to any non-conformances or audit findings that are raised. Develop an action plan and tracker in collaboration with the HPA Team. 
•  People Management: Drive a high-performance culture within the HPA team. Drive a culture of personal and professional development. Living the SAHPRA Values. Drive collaborative leadership. Manage workstream staff members’ compliance with organisational policies and procedures by performing regular performance assessments and implementation of individualised interventions where applicable and escalating further non-compliance. 

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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. 

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REQUIREMENTS: 

• Matric certificate plus a Natural/ Medical Sciences/Clinical engineering/Pharmacy degree (NQF level 8). Registration with the relevant professional body. A postgraduate qualification will be an added advantage.  

EXPERIENCE: 

• Minimum three (3) years’ experience, of which two (2) years must be regulatory in Medical Devices and IVDs. Knowledge and/or understanding of Medical Devices Regulatory Compliance, QMS and Medical Devices licencing legislative requirements. 

DUTIES:

• Evaluate and manage licence applications for medical device establishments and maintain relevant databases. Prepare reports for SAHPRA and relevant advisory committees for compliance-related matters. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the unit. Liaise with international provisions of the Medicines Act and other related Health Acts regarding medical devices and IVDs. Develop and review guidelines and standard operating procedures for Medical Devices Licensing. Proactively audit processes, practices, guidelines, and standard operating procedures for Medical Devices Licensing. Acts as contact person and liaison between Regulatory Compliance, QMS, and Medical Devices Licensing. 
• Facilitate training of Medical Devices Licensing staff on matters related to any legal changes and updates to compliance guidelines. Investigate complaints from Regulatory Compliance for any transgressions against the Medicines Act and other related Health Acts regarding medical devices and IVDs. Communicate with the members from industry regarding the SAHPRA Board resolutions, legislative requirements for medical devices and IVDs. Investigate and attend to industry/applicants’ queries. Capture and maintain data relating to measuring and monitoring of performance metrics and peer-reviewed reports, and record statistics generated. Manage the associated risks and audit queries, and correspondence from applicants and stakeholders. Submit a weekly work plan and output to the Unit manager (quantitative and qualitative reports). Perform other related functions that may arise from time to time.