Openings at South African Health Products Regulatory Authority

Purpose of the role

• The role is responsible to manage the end-to-end evaluation process by ensuring that applications received are uploaded, screened, evaluated and captured on the Tracker/database and, to ensure that the applications are compliant with the Medicines and Related Substances Act (101 of 1965) as amended and the relevant regulatory guidelines.

REQUIREMENTS:

• Matric certificate and appropriate Science Degree Honours at NQF Level 8, as recognised by the South African Qualifications Authority (SAQA), OR a four-year degree in Health Science at NQF Level 8, as recognised by SAQA, and registration with a statutory council if applicable. Certificate in Project Management will be an added advantage.

EXPERIENCE:

• A minimum of five (5) years of relevant work experience with 3 years’ experience in a regulatory environment. Management experience as well as experience in the Medicines Regulatory  environment, and Risk and Software Management will be an added advantage. Valid driver’s license

COMPETENCIES:

Technical Competencies:

• Health Products Authorisations (HPA) Information Management systems.  HPA Processes, legal and regulatory requirements. Occupational Health and Safety. Risk Management. Monitoring, Evaluation, Reporting and Delegation. Business Processes Application. HPA Records Management.

Generic Competencies:

• Demonstrates outstanding written and verbal communication abilities and excels in building strong interpersonal relationships.
• Applies critical thinking and sound judgment to solve problems efficiently. Highly proficient in computer skills and consistently adopts a solution-oriented approach. Maintains composure and effectiveness under pressure, upholds strict confidentiality, and displays both interpersonal and intrapersonal awareness.
• Ensures accuracy and meticulous attention to detail, strong time management, and demonstrates strong planning and organizational skills. Consistently upholds professionalism, honesty, and integrity. Shows innovation, patience, empathy, and courage in decision-making, and possesses advanced conceptual reasoning and systemic thinking abilities.
• Leadership Competencies: Demonstrates tactical leadership capabilities and effectively manages and empowers teams. Leads change initiatives, drives knowledge management, and champions service delivery improvements. Strong problem solving and analytical thinking skills, maintains a strong client and customer focus, and proactively manages stakeholder relationships. Adapts seamlessly to various situations with flexibility and resilience.
• Knowledge of Medicine and Related Substance Act will be an added advantage.

MAIN DUTIES:
Operational Management:
Manage the application receipt and preliminary review to verify that applications are compliant to SAHPRA’s requirements and determine whether the applications may advance to the review phase:

• Verify and ensure that submitted applications are received and recorded on the relevant trackers/databases and medicines register.
• Verify and ensure that technical screening of applications and responses is performed in accordance with the validation, screening templates or checklists, timeously and according to the units work plan and submission schedules. 
• Quality check and approve admin and technical screening in accordance with the validation template or checklist and upload to the file plan.
• Ensure that status information is captured on the tracker/ database by the relevant screeners.

Manage/the allocation, recording and monitoring of applications:

• Compile and maintain a list of the expertise of evaluators.
• Ensure that the tracker is updated routinely by the relevant evaluator coordinator for traceability and transparency of applications.
• Ensure that the applications are allocated based on the level of expertise and availability of evaluators. Monitor applications in progress to ensure timeous interventions and develop  contingency plans for potential problems where applicable.
• Conduct quality control checks on the evaluation reports and queries/approval letters and ensure they are uploaded on the file plan.
• Conduct quality checks on applicable documents and ensure the database records are updated accordingly.

Financial Management:

• Oversee the claims and revenue management process by ensuring that claims are accurately recorded and submitted to Finance timeously. Verify that claim codes reflected on evaluator submission forms are correct to facilitate accurate payments and effective expenditure management. Ensure that revenue information for received applications is properly collated. Promote continuous improvement in cost–benefit outcomes by ensuring that POEs are compiled accurately and consistently

Governance, Risk and Compliance:

• Ensure compliance by verifying that all reports and correspondence are completed using the latest QMS-controlled versions of evaluation letters and templates.
• Conduct self-inspections of work practices, document deviations, and ensure adherence to standard operating procedures and SAHPRA guidelines.
• Develop, maintain, and distribute standard operating procedures (SOPs) and templates.
• Develop work plans and/or programmes to implement the approved strategic direction.
• Support the unit during QMS internal and external audits, including ISO 9001:2015 certification, by promptly addressing non-conformances and audit findings.
• Develop and maintain an action plan and tracking mechanism in collaboration with the HPA Team.

People Management:

• Foster a high-performance culture within the HPA team. Promote personal and professional development. Model the SAHPRA Values. Cultivate collaborative leadership. Ensure workstream staff comply with organisational policies and procedures through regular performance assessments.
• Implement individualised interventions where applicable and escalate cases of ongoing noncompliance.

go to method of application »

Purpose of the role

• The purpose of the role is to co-ordinate the allocation of applications to evaluators to ensure that applications are compliant with the Medicines and Related Substances Act (101 of 1965) as amended and the relevant guidelines. In addition, responsible to manage the workflow of applications by assigning resources to application evaluation.

REQUIREMENTS:

• Matric certificate and appropriate Natural Science or Health Science Degree at NQF Level 7 as recognised by the South African Qualifications Authority (SAQA).

EXPERIENCE:

• A minimum of three (3) years’ relevant work experience. At least one (1) year of experience within a regulatory environment and project management will be added advantage.

COMPETENCIES:

• Technical Competencies: Health Products Authorisation (HPA) Information Management systems. HPA Processes, legal and regulatory requirements. Occupational Health and Safety. Risk Management. Monitoring, Evaluation, Reporting, and Delegation. Business Processes Application. HPA Records Management.

Generic Competencies:

• Demonstrates excellent written and verbal communication skills, strong critical thinking, and sound judgment in problem-solving. Proficient in computer skills and maintains a solutionoriented approach, even under pressure. Upholds confidentiality, accuracy, and attention to detail.
• Strong time management, planning, and organization. Consistently displays professionalism, honesty, integrity, innovation, patience, empathy, and courageous decision-making. Possesses strong conceptual reasoning, systemic thinking, and both interpersonal and intrapersonal skills.
• Leadership Competencies: Tactical Capabilities. Change Management. Knowledge Management. Service
• Delivery initiatives. Problem Solving + Analysis. Client Orientation + Customer-focused coupled with strong stakeholder management. Proactive Stakeholder Management.

MAIN DUTIES:

• Operational Management: Allocate applications and query responses to evaluators (primary and peer evaluators) and Quality Controller/Assurer within agreed timelines. Capture evaluation reports on the dedicated shared drive within time limits. Collate evaluation reports for peer review and/or adjudication. Allocate applications for technical screening based on the screener’s capacity. Monitor and record evaluators' capacity as per allocated timelines. Track and convey application statuses to Portfolio Coordinators. Update the database/trackers upon receiving the evaluation reports following each evaluation stage to ensure the traceability and transparency of applications. Follow up continuously with screener/evaluators to ensure operational priorities are met. Compile and provide relevant statistics and evidence for evaluators and unit performance to the Portfolio Coordinators periodically. Identify and report on performance trends for decision making.
• Governance, risk, and compliance: Check for compliance and ensure reports/letters are completed on the latest QMS-controlled version of the evaluation letters/ templates. Confirm claims receipt and invoices. Adhere to standard operating procedures and SAHPRA guidelines. Maintain, update, and distribute SOPs and templates. Support unit with QMS internal and external audits, including ISO 9001:2015 certification by responding swiftly to any non-conformances or audit findings that are raised. Conduct upskilling and awareness interventions to convey changes or updates to procedures, guidelines, and SOPs.
• Financial Management: Confirmation of claims receipt and invoices. Applies the organisation's policies and complies with procurement and finance procedures.
• People Management: Self-management. Manage own Performance Management and Individual Development Plan. Living the SAHPRA values.