Vacancies at South African Health Products Regulatory Authority

REQUIREMENTS:

• A Matric certificate and a Bachelor’s degree in Information Technology or an equivalent at NQF Level 7 qualification as recognised by the South African Qualifications Authority (SAQA). A minimum of 3 years’ experience in database security, design, support and maintenance. 

COMPETENCIES, SKILLS AND ATTRIBUTES 

• Understanding and managing of the database environment. 
• Good understanding of relational and dimensional data modelling. 
• Ability to maintain data integrity, keep it accessible and prevent unauthorised entry. 
• Must have strong communication skills and good relationship with other team members and stakeholders. 
• Good in SQL scripting. 
• Excellent problem-solving skills and familiar with troubleshooting processes. 
• Must be resilient, assertive and self-driven. 

DUTIES:

• Conduct data user requirement session with relevant stakeholders. 
• Document, validate and verify all collected requirements. 
• Transform database designs and specifications into prototypes and programming integration with other systems. 
• Designs data structures to deliver enterprise grade database design. 
• Analyse user / project requirements and creates an appropriate database design, in conjunction with other developers, according to best practice and organizational initiatives and objectives. 
• Contribute to all phases of the development lifecycle and designs all necessary detailed flow charts and input-output forms/reports. 
• Conduct and facilitate all forms of software testing to ensure product quality. 
• Develop system test cases for quality assurance. 
• Prepare, secure and maintain infrastructure for housing new and/or existing application.
• Day to day support of all application system within the organisation. 
• Produce documentation for all projects completed, which should include Design Documentation, User Requirement Specification, Test Cases. 
• Develop Policies and Standard Operating Procedures to regulate appropriate use of databases with the organization. 
• Play a direct role in negotiating contracts with IT service providers by assessing SAHPRA’s needs related to equipment and services and presenting them to vendors. 
• Participate in supply chain processes to compare pricing and vendor bids within the ICT budget. 
• Participate in policy development and implementation. 
• Mitigate identified risks through effective development of software, systems and etc. 
• Participate in budget development activities and drafting of specifications for procurement. 
• Manage own performance in accordance with performance management processes and individual development plan. Demonstrate commitment to living the SAHPRA values in the execution of duties. 

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REQUIREMENTS:

• A matric certificate and a bachelor’s degree in Computer Science or Computer Engineering or an equivalent NQF level 7 qualification recognised by the South African Qualifications Authority (SAQA) are required. Candidates must have at least five (5) years’ of professional software development experience and a demonstrated record of successfully delivering complex applications. 
• The candidate must have certification in Programming Language-Specific Certifications, Cloud Computing Certifications, Database Development Certifications, Web and Front-End Development Certifications, Software Testing and Quality Assurance Certifications and Agile and Project Management 

COMPETENCIES

• Software Development Life Cycle Framework and best practices. 
• Proficiency in one or more core programming languages, like: JavaScript (for web development), Python (popular in web development, data science, automation), Java (for enterprise applications), C++/C (for system-level programming), Ruby, PHP, Swift, Go, and others. 
• Knowledge of SQL and NoSQL databases, like: MySQL, PostgreSQL, SQLite (SQL-based), MongoDB, Cassandra, Redis (NoSQL-based). 
• Proficiency in one or more core programming languages, like: JavaScript (for web development), Python (popular in web development, data science, automation), Java (for enterprise applications), C++/C (for system-level programming), Ruby, PHP, Swift, Go, and others. 
• Ability to design and query databases efficiently. 
• Understanding of design patterns (e.g., MVC, Singleton, Factory). 
• Familiar with software architecture principles (e.g., microservices, monolithic applications). 
• Familiar with UML diagrams or other modelling techniques. 
• The candidate must have excellent interpersonal, intrapersonal, and communication skills (written and verbal). 
• Ability to think critically, exercise good judgement, and solve problems quickly and effectively. Must possess computer skills and solution orientated. 
• Ability to work under pressure. Ability to maintain high levels of confidentiality. Must be accurate and pay attention to details. Must have time management skills. 
• Must have planning and organising skills. 
• Must always be professional. 
• Must be honest and maintain integrity. 
• The candidate must be innovative, patient and empathetic. Must have courage to make decisions. 
• Must have conceptual reasoning and systemic thinking. 
• Tactical capabilities and sound understanding and change management as well as knowledge management principles. 
• Lead Service Delivery initiatives 
• Strong problem solving and analytical skills. 
• Must be client-orientated and Customer focused. 
• Proactive stakeholder management and relationship-building skills. 

DUTIES

• Design, develop, test, and maintain high-quality software applications, focusing on performance, scalability, and user experience. 
• Collaborate with cross-functional teams to design and implement architecture and design patterns for software systems. 
• Conduct code reviews, ensuring adherence to best practices and high-quality code standards. Provide mentorship and guidance to junior developers. 
• Work closely with stakeholders to understand requirements and deliver solutions that meet business needs. 
• Identify, troubleshoot, and resolve software defects and performance issues in a timely manner. 
• Promote best practices in software development, including code quality, testing, version control, and agile methodologies. 
• Create and maintain comprehensive technical documentation for software systems and features. 
• Stay up to date with the latest industry trends, technologies, and frameworks, and apply them where appropriate to improve the development process and end-product. 
• Participate in policy development and implementation. Mitigate identified risks through effective development of software, systems, etc. 
• Participate in budget development and drafting specifications for procurement. 
• Demonstrate strong self-management skills. 
• Manage own performance in accordance with performance management processes and individual development plan. 
• Demonstrate commitment to living the SAHPRA values in the execution of duties. 

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REQUIREMENTS:

• A matric certificate and a bachelor’s degree in Information Systems or Computer Science or equivalent qualification at NQF level 7 as recognised the South African Qualifications Authority (SAQA). A minimum of three (3) years experience in business analysis, process improvement, or a related discipline. The candidate must have professional certification in Business Analysis Professional (CBAP), Agile Certification (e.g., Certified ScrumMaster), or related certifications will be an advantage. 

COMPETENCIES

• Competent in Business Analysis and Development of Framework. 
• Proficient in tools like SQL, Excel, Tableau, and other BI tools is crucial for gathering, analysing, and visualizing data to identify trends and insights. 
• Understanding how to use tools and techniques to model and document business processes is essential for identifying inefficiencies and areas for improvement. 
• Ability to effectively gather, document, and analyse business requirements from stakeholders. 
• A good understanding of IT systems, databases, and relevant technologies is important for IT business analysts. 
• Knowledge of project management methodologies (like Agile) and tools to plan, execute, and monitor projects. 
• Ability to perform statistical analysis and understand quantitative data to support decision-making. 
• The candidate must have excellent interpersonal, intrapersonal, and communication skills (written and verbal). 
• Ability to think critically, exercise good judgement, and solve problems quickly and effectively. 
• Must possess computer skills. Must be solution orientated. Ability to work under pressure. Ability to maintain high levels of confidentiality. 
• Must be accurate and pay attention to details. Must have time management skills. Must have planning and organising skills. 
• Must always be professional. 
• Must be honest and maintain integrity. 
• The candidate must be innovative, patient and empathetic. 
• Must have courage to make decisions. 
• Must have conceptual reasoning and systemic thinking. 
• Tactical capabilities and sound understanding of change management as well as knowledge management principles. 
• Lead Service Delivery initiatives. 
• Must have strong problem solving and analytical skills. 
• Must be client-orientated and customer focused 
• Proactive stakeholder management and relationship-building skills. 

DUTIES

• Work closely with business stakeholders to understand and document their business /operational needs and objectives. 
• Conduct workshops, interviews, and surveys to gather information. 
• Translate business requirements into detailed technical specifications for developers and other technical teams. 
• Analyse existing business processes to identify inefficiencies, bottlenecks, and areas of improvement. 
• Develop and recommend strategies for process improvement, automation, and cost reduction. 
• Implement process changes and assist with the adoption of new systems and workflows. 
• Collect, analyse, and interpret data to inform decision-making. • Design and implement reports and dashboards that track business performance and KPIs. 
• Provide insights and actionable recommendations based on data analysis. 
• Assist in managing and supporting projects, ensuring that business needs are aligned with technical solutions. 
• Coordinate between business stakeholders and technical teams to ensure seamless communication. 
• Assist with project timelines, scope, and risk management. 
• Communicate findings and recommendations clearly and effectively to both technical and non-technical stakeholders. 
• Maintain comprehensive documentation on business requirements, processes, and system designs. Ensure that stakeholders are kept informed of project progress, issues, and changes. 
• Participating in policy development and implementation. Mitigation of identified risks through effective development of software, systems, etc. 
• Assist with the creation and execution of test plans and user acceptance testing (UAT). Ensure that deliverables meet business requirements and quality standards. 
• Participate in budget development and drafting specifications for procurement. 
• Manage own performance in accordance with performance management processes and individual development plan. 
• Demonstrate commitment to living the SAHPRA values in the execution of duties.

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REQUIREMENTS:

• A matric certificate and a 4-year degree in Pharmacy or a 4-year degree in Health-Sciences-related field (NQF Level 8) as recognised by the South African Qualification Framework (SAQA). Registration with the South African Pharmacy Council (SAPC) where applicable is required. A relevant NQF level 9 qualification in Health Sciences will be an added advantage. 

EXPERIENCE:

• A minimum of three (3) years' relevant post-internship experience.

COMPETENCIES, KNOWLEDGE, AND SKILLS:

• Knowledge and application of the Medicines and Related Substances Act No. 101 of 1965 as amended, and its related Regulations, concerning the regulation of medicines with respect to quality, safety, and efficacy. Knowledge of the technical aspects and evaluation processes relating to the quality efficacy and bioequivalence of medicines. Comprehensive knowledge and understanding of relevant legislation, regulatory guidelines, protocols, standard operating procedures (SOPs), and work instructions applicable to SAHPRA’s regulatory environment. 
• Possess good planning, organizational and interpersonal skills. 
• Self-motivated and can work without supervision. 
• Have good communication skills (written, and verbal) and ability to negotiate, solve conflicts and prepare presentations. 
• Ability to come with innovations, initiate, and demonstrate assertive and leadership qualities. 
• Be dedicated and pay attention to details. 
• Ethical and maintain high level of integrity. 
• Must be willing to travel and work beyond normal working hours. 
• Must have good customer service. 

DUTIES:

Evaluation of new applications and peer-reviewing of new applications/variations: 

• Must produce evaluation reports for new applications and submit them for peer review as well as ensuring compliance with prescribed templates and existing regulatory /scientific standards (depending on the type of application, i.e., Full/partial reviews Q-BE and Reliance. 
• Evaluate Type I and II applications for clinical or quality variation. 
• Follow peer-review process, amend reports to generate a list of queries that will be shared with applicants using prescribed templates (Full/partial reviews Q-BE and reliance). 
• Review other evaluators’ reports according to the prescribed templates and accepted regulatory /scientific standards (Full/partial reviews Q-BE and reliance) 
• Evaluate PI/PIL applications (new applications and responses). 
• Prepare query or feedback to the applicant (approval or rejection letter). 

Evaluate applicant responses for registration/approval of medicines: 

• Produce another evaluation report for application reviews. 
• Follow peer-review process, amend reports to generate a list of queries that will be shared with applicants, where applicable. 
• Review other evaluators’ reports according to the prescribed templates and accepted regulatory /scientific standards. 

Develop and update guidelines, SOPs, and templates: 

• Review existing guidelines, Standard Operating Procedures (SOPs) and templates and update them when necessary. 
• Train new Medicine Registration Officers (MROs) and external evaluators, and attend workshops about latest guidelines, SOPs and templates. 
• Develop new guidelines, SOPs, and templates where applicable. 
• Submit work plans and targets to the Business Unit Manager (qualitative and quantities report). 
• Perform other duties that a senior manager or Business Unit manager may assign to you. 

Participate in technical working groups or special projects and provide support to the Business Unit as well as to the Advisory Committees: 

• Prepare report for the internal working groups and/or advisory committee. Present at advisory committee for complex scientific matters and ensure adherence to SOPs and Guidelines. 
• Provide quality assurance to 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. 
• Execute recommendations from the advisory committee timeously. 

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: 

• Produce evaluation reports for technical screening of applications and submit them for review. 
• Comply with the report review process and amend technical screening report to generate queries for the applicant using correct templates. 
• Review technical screening reports compiled and reviewed by other colleagues or peers.
• Prepare screening feedback to the applicant (Rejection or approval letter). 
• Provide quality assurance to reports and facilitate solutions to technical matters. 

Closing Date: Friday, 05 August 2026

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REQUIREMENTS: 

• A matric certificate and 4-year degree in pharmacy at NQF level 8 as recognised by the South African Qualifications Authority (SAQA). Registration with the South African Pharmacy Council. A relevant master’s degree in pharmacy will be an added advantage. 

EXPERIENCE:

•  A minimum of three (3) years' relevant post-internship experience. 

COMPETENCIES, KNOWLEDGE, AND SKILLS: 

• Knowledge and application of the Medicines and Related Substances Act No. 101 of 1965 as amended, and its related Regulations, concerning the regulation of medicines in terms of quality, safety, and efficacy. Knowledge and understanding of the use of data capturing. 
• Demonstrate strong administrative, planning and organising skills. 
• Must have good communication skills (verbal and written). 
• Must be computer literate (MS Office Suite). 
• Pay attention to details. 
• Ability to work under pressure and with no supervision. 
• Must be able to work in a team, resilient, assertive, innovative and meet deadlines.
• Willingness to work beyond normal working hours where applicable. 

DUTIES:

Technical review of clinical trial applications and provide recommendations for approval/rejection of clinical trial applications: 

• Screen new applications for clinical trials to ensure adherence to SAHPRA requirements. 
• Conduct technical evaluations of applications for clinical trials. 
• Recommend applications for review to the Clinical Trials Expert Committee. 
• Review responses from applicants and recommend a decision (approval or rejection) of clinical trial applications. 
• Communicate the decision (approval or non-approval) or queries to the applicants. Ensure that the status tracker process is finalised or completed timeously for reporting (Finance, performance). 
• Manage application cycles for submission of clinical trials. 

Technical Review of applications to conduct Bioequivalence studies and provide recommendations for approval/rejection of clinical trial applications: 

• Technical screening of new Bioequivalence studies to ensure adherence to SAHPRA requirements. Technical Review of Bioequivalence studies applications. 
• Recommend applications to the Clinical Trials Expert Committee where applicable. 
• Review applicant responses and recommend for approval or rejection of Bioequivalence studies. 
• Communicate the decision (approval or non-approval to the applicants. Ensure that the status tracker process is finalised or completed timeously for reporting. Manage submission of Bioequivalence from receipt to finalisation. 

Provide technical support to appropriate Expert Committee/s and SAHPRA in general: 

• Allocate clinical trials to the external evaluators in accordance with their expert areas. 
• Co-ordinate clinical trials applications and monitor progress of review (follow up with external evaluators). 
• Liaise with advisory committee members and external reviewers. 
• Prepare agenda and documentation to present at the Clinical Trials Expert Committee. 
• Support the proceedings of the Clinical Trial Committee meetings, including the expert consultation meetings. 
• Prepare minutes and recommendations following the meeting of the Clinical trials expert committee. 
• Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings. 

Review safety information, progress reports and any other clinical trials correspondence: 

• Review Serious Adverse Events (SAE) reports, progress reports and other safety reports during the Conduct of Clinical Trials and Bioequivalence studies. 
• Validate the SAE report on the system after review. 
• Present the SAE Reports to Clinical Trials Safety Monitoring Committee / Clinical Trial Committee on critical findings. 
• Set up systems to implement the process of SAE reporting. 
• Advise on improvement of system or any other processes in the Business Unit. 
• Liaise with advisory committee members of the Clinical Trials Safety Monitoring Committee. 
• Prepare agenda and documentation to present at the Clinical Trials Safety Monitoring Committee. 
• Support the proceeding of the Clinical Trial Committee meetings. 
• Prepare minutes and recommendations following the meeting of the Clinical Trials Safety Monitoring Committee. 
• Communicate the recommendations to the external stakeholder following the Clinical Trials Committee meetings. 

Review applications for protocol amendments for clinical trials applications and Bioequivalence studies: 

• Screening and technical review of applications for protocol amendments in line with set timelines in annual operations plan. 
• Allocation of clinical trials protocol amendment to the external evaluators in accordance with expert areas. 
• Advise on improvement of system or any other processes in the Business Unit. 
• Check the status of all applications received to monitor timeline in line with Annual Performance Plan (APP) or Annual Operational Plan (AOP). 
• Attend and respond to queries and complaints related to applications from external stakeholders in time. 
• Update spreadsheet on regular basis. 
• Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting. 

Review applications for additional investigators and sites for clinical trials applications and Bioequivalence studies: 

• Review investigators, change in investigators/Principal investigators or additional sites in line with the set timelines. 
• Check the status of all applications received to monitor timeline in line with the Annual Performance Plan or Annual Operational Plan. 
• Attend and respond to queries and complaints related to applications from external stakeholders in time. Provide statistics on applications reviewed and outstanding in preparation for monthly finance and performance reporting. 

Develop policies, guidelines as well as standard operating procedures for conducting clinical trial: 

• Draft and review existing policies and lead preparation of policy document. 
• Develop and review existing Standard Operating Procedures (SOP) and ensure that there are SOPs in place for services offered by SAHPRA. 
• Ensures the Business Unit complies with the approved Standard Operating Procedures. 

Manage and perform performance assessment of administrative staff and attend to queries addressed to the Clinical Trials Unit: 

• Manage administration staff and ensure that the Business Unit meet the deadlines for queries. 
• Conduct performance assessment for administration staff in the Business Unit. 

Advise and attend to pharmaceutical industry / applicant’s queries or other members of the Public: 

• Investigate and advise pharmaceutical industry / applicant’s queries or other members of the public. 
• Manage resolution of the queries in your area of work. 
• Advise or make recommendations to the Inspectorate and Regulatory Compliance Unit. 
• Represent SAHPRA at the local and international events 
• Arrange meetings with industry task groups and attend external stakeholder meetings. 

Manage the associated risks and audit queries: 

• Attend and support internal and external audit meeting and attending to audit queries.
• Manage and keep records of clinical trials. 

Closing Date: Friday, 05 August 2026

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REQUIREMENTS:

• A Matric or Grade 12 certificate and a postgraduate qualification (NQF Level 9) in Veterinary Science, Veterinary Pharmacology, Animal Health or a related Health Sciences field Registration with the South African Veterinary Council or any other relevant Professional Body will be an added advantage
• A minimum of eight years' experience in medicines regulation, veterinary medicines evaluation or a related scientific regulatory environment of which at least five years must have been at a management or supervisory role
• Demonstrated experience in veterinary medicine registration, scientific evaluation and regulatory decision-making Experience in the development of regulatory policies, guidelines and quality systems A valid driver’s licence. 

KNOWLEDGE AND SKILLS: 

• Extensive knowledge of the Medicines and Related Substances Act and applicable veterinary medicines legislation and regulations. 
• Knowledge of regulatory standards and best practices. 
• Strong understanding of Good Manufacturing Practice (GMP), quality assurance and risk management. 
• Excellent scientific evaluation and analytical skills. 
• Strategic thinking and sound decision-making ability. 
• Excellent report writing and communication skills. 
• Strong stakeholder engagement and negotiation skills. 
• Proven leadership, coaching and people management capability. 
• Sound project management and financial management skills. 
• Proficiency in Microsoft Office applications. 

COMPETENCIES:

• Strategic Leadership 
• Regulatory and Scientific Expertise 
• Governance, Risk and Compliance Management 
• Financial Management 
• People Management and Empowerment 
• Change Management 
• Stakeholder Management 
• Problem Solving and Analytical Thinking 
• Customer Focus 
• Planning and Organising 

DUTIES:

• Provide strategic leadership and operational management of the Veterinary Medicines Unit Manage the evaluation and registration of new veterinary medicines, generic medicines and variations Oversee the scientific review and quality assurance of veterinary medicine applications
• Lead the development, implementation and review of veterinary medicine regulations, policies, guidelines and Standard Operating Procedures
• Manage regulatory risk, governance and quality management systems within the Veterinary Medicines Unit
• Foster and maintain strategic stakeholder relationships with industry, government departments and institutions, academia and international regulatory authorities Lead, develop, and manage a multidisciplinary team through effective people management and performance management
• Manage the Veterinary Medicines Unit's operational plans, budgets, reporting and resource allocation Represent SAHPRA on relevant technical committees, forums and regulatory initiatives. 

Closing Date: Friday, 07 August 2026