Current Jobs at South African Health Products Regulatory Authority

REQUIREMENTS: 

• A Matric Certificate plus National Diploma, (NQF level 6) as recognised by SAQA in Office Management and Technology; Office Administration and Management / Business Administration / Public Administration /Public Management or a relevant equivalent qualification. A Bachelor’s degree (NQF level 7) in a related field will be an added advantage. 
• A minimum of six (6) year’s as Senior Secretarial / Assistant or Administration experience. Three (3) years of experience as Personal Assistant or Executive Assistant to Senior / Executive Manager in a regulatory environment will be an added advantage. 
• Strong proficiency in Microsoft Office Suite packages and an ability to work with data. Regulatory environmental experience will be an added advantage. Valid driver’s licence is essential. 

DUTIES: 

• Developing and implementing an effective office administration system for the office of the CEO 
• Provide administrative support to the CEO to ensure the CEO’s schedule is managed effectively 
• Provide comprehensive support services to the CEO that ensure outstanding communication and responsiveness 
• Provide calendar management; prioritize inquiries and requests, troubleshoot conflicts with little guidance, and make judgments and recommendations to ensure smooth day-to-day engagements 
• Ensure presentations, speeches, biographies, briefing notes etc are drafted or provided timeously for meetings, workshops and conferences 
• Type letters /Memos or review documents as per Executive request, and follow up on actions/decisions from the CEO to Management 
• Prepare and edit correspondence, presentations, reports, and other communication. Manage all scheduling and travel logistics for the CEO 
• Continually monitor the flow of information going in and out of the CEO’s office 
• Compiling of meeting documents and agendas for the meeting 
• Manage the diary and schedule meetings and appointments on behalf of the CEO 
• Arranging catering with all kinds of dietary requirements and ensuring that all relevant packs/stationery for the workshop are available, and that the venues meet all operational requirements 
• Processing of subsistence and travelling claims 
• Manage the office petty cash and procurement of goods and services and manage the office resources 
• Oversee the reconciliation of claims by the CEO and/or Office Manager 
• Planning and Coordinate functions, events and operational projects 
• Attend relevant internal and external meetings as per request by the CEO and/or Office Manager.

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REQUIREMENTS: 

• Matric certificate and appropriate 4-year Degree in Pharmacy or related qualification at NQF level 8 as recognised by SAQA and registration with a Professional Body. A relevant Master’s Degree will be an added advantage. A valid driver’s license. 

EXPERIENCE:

• Grade 1 – A minimum of two (2) years of clinical experience post Internship and Community Service. Regulatory experience will be an added advantage. 
• Grade 2 – A minimum of five (5) years of clinical experience post Internship and Community Service of which two (2) years should be within regulatory experience. 

DUTIES:

• Evaluation of new applications and peer-reviewing of new applications: Generate evaluation report(s) for each new applications (Generics) in compliance with required template and adopted regulatory /scientific standards and submit for peer review. Following peer review process amend the report (s) accordingly to generate a list of queries to the applicant using the correct templates. Prepare report for the internal working groups and where necessary present at advisory committee for complex scientific matters. 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 for registration/approval of medicines: 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 for the internal working groups and where necessary present at advisory committee for complex scientific matters. 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 for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: Generate technical screening evaluation report(s) for each application. 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 aren’t in place. Provide regular work-plans and output to the unit manager (qualitative and quantities report). Perform any other related duty as requested by manager/senior manager. 
• Form part of technical working groups or special projects and provide support to the unit as well as to the Advisory Committees: Participate in special projects and registration group. Lead and manage assessments peer review and discussion working group where relevant. Compile discussion documents and reports. Provide regular trainings to new internal MRO’s and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for SAHPRA management/ RC meeting. 
• Audit and Risk Management: SOP’s 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, WHO and international standards.

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REQUIREMENTS: 

• Matric certificate and a Pharmaceutical Master’s Degree at NQF level 9 as recognised by the South African Qualifications Authority (SAQA). Management qualification will be an added advantage. Proof of current registration with the South African Pharmacy Council (SAPC). 

EXPERIENCE: 

• A minimum of ten (10) years’ relevant experience in the medicines regulatory field, of which five (5) years must be at a supervisory / management level (Level 09 – 12) supporting business operations. Experience in the application of the Medicines and Related Substances Control Act 101 of 1965 (as amended), and its related Regulations. Knowledge of database management will be an added advantage. 

DUTIES:

• Manage and control the operations, processes, and innovations of the Unit: Developing and coordinating systems for management of all operations of the Unit. Managing the development, implementation and maintenance of regulations, guidelines, policies, and procedures pertaining to naming and scheduling of unregistered and registered medicines, to ensure alignment with international and national protocols, legislations and other legal requirements of the Medicines Act. Preparing monthly, quarterly, and annual reports for work done within the Unit, including monitoring of the timelines. Preparing reports to be submitted to relevant technical committees for their information, discussion, review and/or recommendation in accordance with prescribed legal requirements and standard operating procedures of SAHPRA. Managing general financial budgeting, human resources, and performance of the Names and Scheduling Unit. Performing such other functions as the Senior Manager: Clinical Evaluations Management (CEM) may duly allocate or delegate from time to time. 
• Ensure effectiveness of the Unit operational processes: Developing operational plans and budget for the Unit. Developing and implementing Annual Performance plan (APP) for the Unit. Ensure that the unit is aligned with the organizational needs and that resources are utilized in the most effective and efficient method. Analyzing information and processes and developing more effective or efficient processes to optimize operations, processes and strategies. Managing, developing, reviewing, and improving the accuracy of databases. Managing operations, processes, and projects within the unit. Developing (and reviewing) internal policies, in collaboration with senior management. Evaluating and improving security (physical, information, cyber). 
• Risk Management: Identify and manage risks within the unit. Ensure that critical controls are in place and are effective. Undertake regular risk mapping exercises within the business unit. Working with the Risk team to promote an embedded risk culture. Ensure that the business unit is kept up to date with pending regulatory changes, trends, and best practices and assess the potential impact of these changes on the business unit’s processes and strategies. Develop business unit continuity plans that are fit for purpose and ensure unit resilience. 
• Finance and Audit Management: Reviewing and ensuring submissions of revenue line listings and supporting evidence are done in line with the Finance Reporting SOP by the 7th of each month to ensure financial sustainability of the Programme. Ensure that the Programme attains and maintains an unqualified overall AG Audit outcome on previous year’s performance through Implementation of internal audit recommendations. Ensure financial sustainability of Names and Scheduling Unit. Submit annual budget estimates to the senior manager and monthly review of finance variations for finance reporting. Perform administrative duties as and when required for the efficient and effective running of the business unit, including capturing of data into the unit tracker/line listing. 
• Manage and support Names and Scheduling Committee: Manage the training of external reviewers on SAHPRA templates, policies, and guidelines. Ensure the correctness of Names and Scheduling Committees recommendations. Oversee the execution of Names and Scheduling Committees recommendations. Monitor and evaluate performance of external reviewers.

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Key Responsibilities include but are not limited to: 

• Strategic Leadership: Provide technical leadership on clinical and non-clinical assessments for biological medicines, aligning with local and international regulatory strategies, WHO standards, and other National Regulatory Authorities (NRAs). 
• Advisory Role: Advise on SAHPRA regulations, policies, and guidelines, ensuring compliance with global standards for biological medicines, including vaccines and biotherapeutics. 
• Application Evaluation: Conduct detailed assessments of safety and efficacy aspects in applications for biological medicines (biotherapeutics, biosimilars, and vaccines) in compliance with the Medicines and Related Substances Act (Act No. 101 of 1965). 
• Peer Review and Mentorship: Provide critical and analytical feedback as a peer reviewer, ensuring thorough evaluation of clinical and non-clinical sections of biological submissions. Train and mentor SAHPRA staff to enhance technical capacity. 
• Global Collaboration: Represent SAHPRA in international regulatory forums, engage with industry stakeholders, and drive innovation in regulatory science. 

 Performance Expectation include but are not limited to: 

• Collaborate effectively with multidisciplinary teams and engage with industry stakeholders on regulatory matters. 
• Transfer skill to SAHPRA staff and stakeholders on Biological Medicine (Vaccine). 
• Maintain resilience, adaptability, and a commitment to excellence in regulatory science. 
• Champion innovation in regulatory science to improve the efficiency and effectiveness of clinical assessments for biological medicines. 
• Adhere to South African data protection laws and SAHPRA's specific data protection policies 

Application Criteria: 

Qualifications and Expertise 

Essential: 

• B. Pharm Degree or MBChB with a Master’s in Pharmacy (NQF) Level 09) as evaluated by South African Qualifications Authority (SAQA), 
• Registration with professional body 
• A minimum of 10 years of experience in evaluating safety and efficacy for biological medicines, including product information and patient information leaflets. 
• Proven knowledge of international guidelines and regulatory standards for clinical aspects of biological medicines. 

Preferred: 

• Postgraduate qualifications in virology, vaccinology, or pharmacology of biotherapeutics. 
• Expertise in clinical trials, biological dossiers, and regulatory compliance. 
• Experience in hybrid or remote collaboration models. 

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Key Responsibilities include but are not limited to: 

•  Strategic Leadership: Provide technical leadership on pharmacovigilance (PV) strategies informed by local and international reports, interventions, and guidelines from the WHO and other National Regulatory Authorities (NRAs). 
•  Regulatory Decision-Making: Make or recommend regulatory decisions on vaccines and biological products based on comprehensive reviews and assessments. 
•  Signal Detection and Investigation: Conduct signal detection, investigate adverse events, and analyse safety data from diverse sources to support informed decision-making. 
•  Capacity Building: Lead training and development initiatives to enhance pharmacovigilance expertise among SAHPRA staff and stakeholders. 
•  Global Collaboration: Represent SAHPRA in international forums and collaborate with global regulatory bodies to advance pharmacovigilance frameworks and practices. 

Performance Expectation include but are not limited to: 

•  Foster a culture of pharmacovigilance awareness within the organization. 
•  Create and maintain effective pharmacovigilance systems and processes that ensure the timely detection, assessment, understanding, and prevention of adverse drug reactions . 
•  Timely submission of required safety reports to regulatory authorities and other relevant stakeholders. 
•  Develop and deliver training programs that enhance the knowledge and skills of staff, fostering a culture of pharmacovigilance excellence. 
• Utilize advanced signal detection methodologies to proactively identify emerging safety issues.
• Contribute to a robust peer review process that identifies potential safety and efficacy concerns in a timely manner.
• Consistently deliver high-quality, evidence-based clinical assessments that meet deadlines and contribute to well-informed regulatory decisions.
• Collaborate effectively with multidisciplinary teams on PV-related projects.
• Strong analytical and communication skills to interpret safety data and communicate complex information effectively.
• Lead and mentor teams in a dynamic regulatory environment.
• Manage multiple priorities and deadlines efficiently with strong organizational skills.
• Proactively identify areas for improvement within SAHPRA's PV system.
• Conduct thorough reviews and assessments of vaccines and biological products.
• Make informed regulatory decisions on these products based on safety data analysis.
• Provide sound recommendations to support the decision-making process.

Adhere to South African data protection laws and SAHPRA's specific data protection policies

Qualifications and Expertise

Essential:

• MBChB degree with a Master’s in Public Health or Clinical Pharmacology (NQF) Level 09 as evaluated by South African Qualifications Authority (SAQA), with
• Registration with the professional bodies.
• At least 10 years of experience in public health programs or clinical research.
• Active participation in regional or international regulatory associations or advisory bodies

Preferred:

• A PhD in public health or pharmacology.
• Experience in hybrid or remote collaborative work environments

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Key Responsibilities include but are not limited to:

• Strategic Leadership: Provide technical leadership on local and international regulatory strategies for biological medicines, aligned with guidelines from WHO and other National Regulatory Authorities (NRAs).
• Advisory Role: Advise on SAHPRA regulations, policies, and guidelines for biological medicines, including vaccines and biotherapeutics.
• Application Assessment: Evaluate quality (Chemistry, Manufacturing, and Control – CMC) aspects of registration applications for vaccines, biosimilars, and biotherapeutics to ensure compliance with relevant legislation and international standards.
• Quality Assurance: Act as a peer reviewer and mentor for quality assessments, ensuring thorough and accurate evaluation of biological submissions.
• Capacity Building: Lead training and mentoring initiatives to enhance technical expertise within SAHPRA.
• Global Collaboration: Liaise with industry stakeholders and international regulatory bodies to advance regulatory best practices.

Performance Expectation include but are not limited to:

• Demonstrate strong analytical, leadership, and problem-solving skills to address complex regulatory challenges.
• Develop and implement strategies to ensure SAHPRA's quality assessment of biological medicines adheres to the highest ethical and scientific standards.
• Consistently deliver high-quality, evidence-based quality assessments that meet deadlines and contribute to well-informed regulatory decisions.
• Develop and deliver training programs that effectively transfer knowledge and skills to colleagues, fostering a strong team of Biological product quality assessors within SAHPRA.
• Be an effective mentor and team player with excellent collaboration and communication skills.
• Maintain strong organizational skills and resilience in a fast-paced environment.
• Adhere to South African data protection laws and SAHPRA's specific data protection policies

Qualifications and Expertise

Essential:

• B. Pharm Degree with a Master’s in Pharmacology (NQF) Level 09) as evaluated by South African Qualifications Authority (SAQA), or a PhD in Biomedical Sciences or a related qualification (NQF Level 10)
• Registration with the professional bodies
• A minimum of 10 years of experience in compiling and/or reviewing quality aspects of biotherapeutic or vaccine Common Technical Document (CTD) dossiers.
• Strong knowledge of international guidelines and regulatory standards for biological medicines.

Preferred:

• Postgraduate qualifications in biotherapeutics/vaccine development, pharmaceutics, or the regulation of biological medicines.
• Experience in hybrid or remote collaborative work environments.