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SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)
 
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CALL FOR EXPRESSION OF INTERST
 
EXTERNAL EVALUATORS 
 
The South African Health Products Regulatory Authority (SAHPRA) hereby invite expression of interest for candidates to serve as External Evaluators for Renewals Unit. 
SAHPRA is a Schedule 3A Public Entity established in terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) to oversee the regulation of medicines, medical devices, and in vitro diagnostics (IVDs) intended for human and animal use; the licensing of manufacturers, wholesalers and distributors of medicines, medical devices and IVDs; and the conduct of clinical trials. 
 
REQUIREMENTS
The External Evaluators are appointed in terms of section 3 (5) of the Medicine’s Act, as amended to assist the Authority in carrying out its functions. These fully qualified external evaluators are crucial to supplementing the skills and experience of the Authority. 
Expression of interest is required in the following disciplines: 
• One (1) external evaluator for the evaluation of Veterinary medicine renewals applications. 
• Two (2) external evaluators for the evaluation of the clinical aspects (clinical pharmacology/internal medicine/clinical epidemiology/oncology/virology) of the renewals application 
• Two (2) external evaluators for the evaluation of Good Practices Compliance aspects of the renewals applications 
• Two (2) external evaluators for the evaluation of the quality aspects of the renewals application 
 
Relevant Qualifications: Appropriate degree in pharmacy/pharmaceutical sciences, medicine/pharmacy/pharmaceutical science and natural sciences.). BVSc/BVMCH degree. 
Applicant must be in good standing with the regulatory board/ council with which he/ she is registered where applicable. 
Exclusions:
- he or she does not meet the minimum requirements; 
 
TERM OF OFFICE 
The term of office for external evaluators is three (3) years effective from date of appointment by the CEO and may be appointed for a further term(s). 
 
Registration with the statutory regulatory board/council relating to his/her profession where applicable is recommended. 
No person shall be eligible for appointment as an Expert, if: - 
- he or she is conflicted in terms of SAHPRA Policy on Management of Conflict of Interest (GOV02); 
- he or she is disqualified under the Relevant Act applicable to his or her profession from practising as such; 
- he or she has been found guilty of improper or disgraceful conduct at an inquiry held under ambit of the relevant Act; 
- he or she is a patient as defined in section 1 of the Mental Health Care Act, 2002 (Act No. 17 of 2002); 
- he or she has been convicted of an offence in respect whereof he or she was sentenced to imprisonment without the option of a fine or in the case of fraud;
 
 
PROCEDURE
• A comprehensive CV, qualification/s and a motivation expressing area of expertise must be submitted online at https://apply.sahpra.org.za:6006/ 
• Only documents in pdf must be uploaded. 
• Further communication will be limited to nominated candidates with appropriate skill sets. 
• Closing date for nominations is Tuesday, 06 August 2024 at 16h30. No late nominations will be accepted. 
 
Enquiries: Ms Mukona Mphidi at mukona.mphidi@sahpra.org.za







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The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest. 
 
Please note that this is a re-advertisement, previous applications will not be considered. Those who previously applied are encouraged to re-apply. 
 
MANAGER: RADIATION CONTROL 
SALARY LEVEL 13: R1 177 554 – R1 249 831 PER ANNUM (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 025/2024 
CENTRE: PRETORIA 
 
REQUIREMENTS: Matric Certificate and B.Sc. Degree with Honours in Medical Physics at NQF Level 8 as recognised by SAQA and Professional registration with the HPCSA as a Medical Physicist for at least Five (5) years OR MSc Degree in Nuclear Science or Radiation Science at NQF Level 9 as recognised by SAQA. Valid driver’s license. 
 
EXPERIENCE: Minimum of ten (10) years’ experience in any/a combination of the three fields, including radiation oncology, nuclear medicine, and diagnostic radiology as a requirement. Minimum eight (8) years of managerial experience. Knowledge of and experience with relevant national legislation, international standards, and best practices, e.g., IAEA requirements. 
 
COMPETENCIES, KNOWLEDGE, AND SKILLS: Advanced knowledge and understanding of relevant legislation, protocols, standard operating procedures, and work instructions. Management of operational plans, business plans, and budgeting. Performance management skills. Self-motivated and able to work independently. Ability to manage a variety of cross-functional team members. Competent in problem-solving, research skills, and team building. Attention to detail. Information evaluation. Decision making. Objectivity. Resilience. Communication skills (verbal, written, negotiation, conflict management, presentation). Interpersonal skills. Assertiveness. Ethical behaviour. Customer/Licensee service. Planning and organizing skills. Team management. Flexibility. 
 
DUTIES: Manages and controls the operations, processes, and innovations of the Radiation Control Unit: Develops and coordinates systems for the management of all operations of the Radiation Control Unit. Manages the regulation of ionizing and non-ionizing radiation sources. Manages the development, implementation, and maintenance of regulations, guidelines, policies, and procedures pertaining to the regulation of ionizing and non-ionizing radiation sources, to ensure alignment with international and national protocols, legislations, and other legal requirements. Prepare monthly, quarterly, and annual reports for work done within the Radiation Control Unit including monitoring of the timelines. Prepares reports to be submitted to the relevant technical committee for their information, discussion, review, and/or recommendation to the relevant advisory committee in accordance with prescribed legal requirements and standard operating procedures of SAHPRA. Manages surveillance mechanisms to detect, assess and prevent adverse reactions related to ionizing and non-ionizing radiation. Represents the South African regulatory authority in the global arena through active and meaningful participation. Manages relationships and agreements, such as memoranda of understanding with international partners where relevant. Manages compliance to service level agreements with outsourced support services to ensure achievement of agreed quality and delivery standards. Manages general financial budgeting, human resources, and performance of the Radiation Control Unit. Performs such other functions as the Senior Manager: Medical Devices & Radiation Control may duly allocate or delegate from time to time. 
 
Internal operational processes (Ensures the effectiveness of Radiation Control Unit operational processes): Develops operational plans and budget for the Radiation Control Unit aligned with organizational needs and ensure the most effective utilization of resources. Manages, reviews, and optimizes operations and processes. Manages, develops, reviews, and improves the accuracy of databases. Manages operations, processes, and projects between the four sub-units. Manages effective utilization of resources to enhance value for money. Develops (and review) internal policies, in collaboration with senior management. Evaluates and improve security (physical, information, cyber). 
 
Regulatory Control (Manages the appropriate development, evaluation, and continuous improvement of regulatory control): Advising on and leading processes to improve regulatory control and cooperative governance. Managing research projects and new developments in these fields. Managing international, regional, and national technical cooperation projects. Managing regulatory systems for radiation control. Identifying gaps, overlaps, and shortcomings in the regulatory control and cooperative governance processes. Maintaining confidentiality and ethical behaviour. 
 
Human capital (Builds human capital in the Radiation Control Unit): Training and managing Deputy Managers reporting to this role to ensure they have the skills required by the organization and can achieve their performance objectives. Working with the Senior Manager: Medical Devices & Radiation Control and relevant functional heads to develop plans and procedures for information and knowledge management and the sourcing, acquisition, and development of staff with required critical skills. Ensuring that a high level of integrity is maintained by staff members by promotion of high ethical conduct and maintenance of high-performance standards. 
 
Communications (Implements internal communication and incident reporting procedures): Managing the effective, timeous communication and consulting thereon regarding issues relating to ionizing and non-ionizing radiation sources. Liaising with representatives from industry and international regulators, and other relevant stakeholders to ensure appropriate and correct information and establishment of productive and relevant relationships. Liaising with senior management and the legal and communications departments for advice and to clarify established SAHPRA systems and methodologies. Providing comments, inputs, and advice on international standards and guidance documents, representing the interests of South Africa as a member state of the IAEA, under the guidance of senior radiation scientists and senior management. Managing investigation of incidents and accidents, and the formulation of appropriate communications with licensees, other regulatory authorities, and the general public, in collaboration with the Deputy Managers and under the guidance of the Senior Manager: Medical Devices & Radiation Control. Representing SAHPRA interests on international, regional, and national levels (forums, committees, etc.). Maintaining confidentiality and ethical behaviour. 
 
 
INSTRUCTIONS TO APPLICANTS (HOW TO APPLY): Interested applicants who meet the above requirements should forward their applications accompanied by signed covering letter attached to the comprehensive CV with the names and email addresses of three (3) referees clearly reflecting the name of the position and post reference number, and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable. 
  • Applications without the aforementioned documents/information will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA). 
  • A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications. 
  • No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date, will not be considered. 
  • Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful. 
  • It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA. 
 
 
Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment. All shortlisted candidates will be subjected to a technical exercise that intends to test relevant knowledge, skill and technical elements of the job. 
 
SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s. 
 
Interested persons who meet the above-stated qualifications should forward their applications which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and Identity Document. ONLY shortlisted candidates will be required to submit certified copies of qualifications and other related documents on or before the day of the interview following communication from Human Resources. 
 
SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act No. 4 of 2013. We will use your personal information provided to us for the purpose of recruitment only and more specifically for the purpose of the position/vacancy you have applied for. In the event your application was unsuccessful, SAHPRA will retain your personal information for internal audit purposes as required by policies. 
 
Applications should be submitted through the SAHPRA Website Online Portal: SAHPRA website (https://www.sahpra.org.za) – About Us – Vacancies. 
 
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (APPLICATIONS SENT TO THIS EMAIL ADDRESS WILL NOT BE CONSIDERED FOR THE RECRUITMENT PROCESS). 
 
The closing date is 05 August 2024 at 16H00.