Evaluator Coordinator (Ref No.: SAHPRA 52 of 2025/26) at South African Health Products Regulatory Authority

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.