Fresh Roles at South African Health Products Regulatory Authority

REQUIREMENTS:

• Matric certificate and 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 SAQA. A relevant Master’s qualification at NQF level 9 as recognised by SAQA will be an added advantage. Valid driver’s licence. 

EXPERIENCE:

• Grade 1: Four-year Bachelor of Pharmacy degree NQF or Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.
• Grade 2: Four-year Bachelor of Pharmacy degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and a minimum of three (3) years of experience in a pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment or an Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA, plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.

DUTIES:

• Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform pre- and post-registration inspections on information submitted in a medicine application dossier.
• Perform a once-off evaluation on information submitted by HCR (Applicants). Work closely across inspection teams, SAHPRA departments, and external regulators to ensure inspection activities are planned and communicated effectively.
• Evaluate Standard Operating Procedures (SOPs) of the Inspectorate for compliance with GMP/GWP guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled appropriately. Prepare reports for SAHPRA and relevant Advisory Committees and the Finance Unit.
• Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the Inspectorate Unit. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues.
• To provide advisory support to key stakeholders, including participation in regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection related resources and that all relevant records and evidence are sufficiently maintained for audit purposes.

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REQUIREMENTS:

•  Matric certificate and appropriate four-year degree in Pharmacy at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) and registration with a Professional Body (South African Pharmacy Council). A relevant Master’s degree will be an added advantage.  

EXPERIENCE:

• Grade 1 – A minimum of two (2) years of relevant experience post internship and community service. Regulatory experience will be an added advantage. 
• Grade 2 –A minimum of five (5) years of relevant experience post internship and community service. Regulatory experience will be an added advantage. 

DUTIES: 

• Evaluation of the name and schedule of new applications. 
• Evaluation of new application’s PI/PILs. 
• Evaluate proprietary name change applications. 
• Facilitate the evaluation of new chemical entities and rescheduling applications. 
• Allocate applications to reviewers for evaluation and follow-up thereof. 
• Identify schedules for substances, new chemical entities, authorised prescribers and update the schedules accordingly.
• Prepare a submission to the Minister of Health for approval of amendments of the schedules. 
• Support and prepare reports/documents for the Names and Scheduling Advisory Committee. 
• Referral of applications to various advisory committees and execution of recommendations thereof. 
• Responsible for updating standard operating procedures, templates, guidelines and applicable documents as per the defined processes. 
• Preparation of documents and presentations as requested by the Manager, Senior Manager, the Chief Regulatory Officer and the Chairperson of the committee. 
• Prepare, attend, and participate in discussions during meetings. 
• 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 Office of the Chief Regulatory Officer. 
   

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REQUIREMENTS:

•  Matric certificate and post-matric certification/Diploma with Training/Certification as a qualified post-basic Pharmacist Assistant or degree in health sciences and registration with a Professional Body. Basic Pharmaceutical knowledge is a requirement.

 
EXPERIENCE:  

• One (1) to two (2) years of experience with MS Office (Excel and Word), email/Outlook, office administration and filing. Regulatory experience will be an added advantage. 

DUTIES:

• Screen and admin support of SAEs reported during the clinical trial process: Quality admin screen SAE reports for completion. Upload SAE correspondence and related documentation following standard operating procedures (SOP) and save on the shared drive. Capture the report on the SAE spreadsheet/tracker. Allocate SAE correspondence to technical staff and monitor reports received. Allocate correspondence to technical staff. 
• SAE data management - VigiFlow database and assist with data information: Capture the SAE reports on VigiFlow database – ensure all the relevant fields are filled and all MedDRA terminologies are properly indicated for useful data. Assist in extracting information relating to a clinical trial in question or a sample, as determined by the Assessor from time to time, based on trends.
•  Attend stakeholder queries on SAEs and assist with other activities related to safety reporting: Identify SAEs reports with deficiencies and request the missing information. Type the letters on Serious Adverse Events Reports as applicable and mailing correspondences to applicants. Attend to queries relating to SAEs or escalate to the responsible Assessor. Assist in attending to internal and external audit queries. 

go to method of application »

REQUIREMENTS:

• Matric certificate and 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).
• A relevant Master’s qualification at NQF level 9 as recognised by SAQA will be an added advantage. Valid driver’s licence.

EXPERIENCE

• Grade 1: Four-year Bachelor of Pharmacy degree and registration as a Pharmacist with the SAPC at NQF level 8 as recognised by SAQA plus a minimum of three (3) years’ experience as a practising pharmacist post community service, of which two (2) should be in pharmaceutical regulatory environment.
• Grade 2: Four-year Bachelor of Pharmacy degree and registration as a Pharmacist the SAPC at NQF level 8 as recognised by SAQA plus a minimum of five (5) years’ experience as a practising pharmacist post community service, of which three (3) should be in pharmaceutical regulatory environment.

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REQUIREMENTS: 

• Applicants must be in possession of a Matric certificate and an appropriate degree in Nuclear Medicine/Radiography/ Biomedical Engineering/Diagnostic Radiographer/Physics/Medical Physics or related equivalent qualification at NQF level 8 as recognised by the South African Qualifications Authority (SAQA).
• Professional registration with the HPCSA (current registration to be submitted with application). Valid driver’s licence.  

EXPERIENCE: 

• Minimum of three (3) years working as Clinical Engineer/Biomedical Engineer/Diagnostic Radiographer. Working knowledge of and experience in relevant national legislation and international standards.
• Computer Literate. Working experience in administration, data management and supervisory skills will be an added advantage. 

DUTIES: 

• Review and verify license applications for completeness, correctness, and compliance.
• Utilise database to process licence applications for listed electronic products.
• Reconcile receipts and follow up on incomplete transactions.
• Follow up on defaulters and dispatch renewal notifications. Follow up on defaulters of annual returns through inspections.
• Support the Deputy Manager and Senior Manager to respond to the queries from the industry related to the listed electronic products.
• Engage with industry stakeholders through training/workshop to enhance compliance with regulatory requirements of listed electronic products for non-ionising devices. Processing import and export authorities.
• Process radiation over-exposure notifications. Compile and update a register for all radioactive sources.