Manager: Names and Scheduling at South African Health Products Regulatory Authority

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.