SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

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MEDICINE REGISTRATION OFFICER: RENEWALS X6 
SALARY: R788 910.00 – R837 326.00 (TOTAL COST TO COMPANY) 
Ref No.: SAHPRA 036/2023 
CENTRE: Pretoria 
 
REQUIREMENTS: • Appropriate 4-year Bachelor of Pharmacy Degree or 4-year Natural Science Degree (B-Pharm degree - registration with the SAPC as a Pharmacist). 
 
EXPERIENCE: • A minimum of 8 years medicines regulatory experience. Knowledge of technical evaluation of quality, safety and efficacy aspects of medicines. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: * Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. * Knowledge of requirements for medicine Product Quality Reviews, the associated technical aspects of manufacturing and relevant Good Manufacturing Practices, as per SAHPRA GMP. * Knowledge of technical aspects for evaluation of quality and efficacy of bioequivalence of medicines. * Comprehensive knowledge and understanding of relevant legislation, guidelines, protocols, standard operating procedures, and work instructions as outlined by regulatory authorities. * Good planning, organizational and interpersonal skills. * Self-motivated and able to work independently. * Decision making informed by technical expertise. * Good communication skills (written, verbal, negotiation, conflict management, presentation). * Innovative thinking, initiative, assertive and leadership qualities. * Dedication and accurate work. * Ability to manage a variety of cross-functional team members. * Ethical behaviour. * Computer skills (knowledge of MS Office). * Must be willing to travel and work irregular hours. * Customer service. *A valid driver’s licence. 
 
DUTIES: • Evaluation and peer-reviewing of renewal applications: * Evaluate and generate evaluation report(s) for renewal applications (Generics) in compliance with required template and adopted regulatory and scientific standards as per GMP PIC/s guidelines, EMA renewal guidelines etc and submit for peer review. * Peer review evaluation reports, in compliance with good review practice and draft peer reviewed report. * Request QA, expert advice or send to technical committee meeting if necessary and submit signed report for filing and further processing. * Following peer review process, amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. * Prepare reports or memos for the internal working groups. * 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 of renewal applications: * Evaluate and 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 and record outcomes for the internal working groups, technical meetings or committee meeting. * 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 of renewal applications: * 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. 
• 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 are not in place. * Provide regular work-plans and output to the unit manager (qualitative and quantitative report). * Perform any other related duty as requested by manager/senior manager. 
• Participate in technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: * Participate in special projects as necessary based on technical and operational needs of the unit. * Lead and manage assessments peer review and discussion working group where relevant. * Compile discussion documents and reports. * Take comprehensive notes of discussions of relevant discussions. 
• Risk Management and Audit: * SOPs 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/VICH, WHO and international standards and use the most current SAHPRA templates and guidelines. 
 
 
INSTRUCTIONS TO APPLICANTS: All applications must: 
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees 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. 
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS. 
• 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. 
 
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. 
 
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS). 
 
CLOSING DATE: 03 August 2023 at 16H00.



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MANAGER: RADIATION CONTROL 
Salary: Level 13 (R1 126 846.00 – R1 196 011.00) TOTAL COST TO COMPANY 
Ref No.: SAHPRA 025/2023 
CENTRE: PRETORIA 
 
REQUIREMENTS: *B.Sc. Degree with Honours in Medical Physics. *Professional registration with the HPCSA. 
 
EXPERIENCE: *10 years’ experience in any/a combination of the three fields, including radiation oncology, nuclear medicine, and diagnostic radiology as a minimum requirement. *Minimum 8 years of managerial experience. *Knowledge of and experience with relevant national legislation, international standards, and best practices, e.g., IAEA requirements. *Valid driver’s license. 
 
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 by: 
• 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 by: 
• 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 by: 
• 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: of 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 by: 
• 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: All applications must: 
• Be submitted with a covering letter clearly reflecting the name of the position and post reference number, be signed, accompanied by a comprehensive CV, the names and email addresses of 3 referees and recently certified copies of ID, required qualification/s (matric included) and driver’s licence where applicable. 
• Applications without the aforementioned 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. 
• Applications must be submitted by email to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS. 
• 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. 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. 
 
Enquiries: Ms S. Molepo, Email: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS). 
 
CLOSING DATE: 27 July 2023 at 16H00.