Medicine Registration Officer: Names and Scheduling needed at South African Health Products Regulatory Authority

REQUIREMENTS:

•  Matric certificate and appropriate four-year degree in Pharmacy at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) and registration with a Professional Body (South African Pharmacy Council). A relevant Master’s degree will be an added advantage.  

EXPERIENCE:

• Grade 1 – A minimum of two (2) years of relevant experience post internship and community service. Regulatory experience will be an added advantage. 
• Grade 2 –A minimum of five (5) years of relevant experience post internship and community service. Regulatory experience will be an added advantage. 

DUTIES: 

• Evaluation of the name and schedule of new applications. 
• Evaluation of new application’s PI/PILs. 
• Evaluate proprietary name change applications. 
• Facilitate the evaluation of new chemical entities and rescheduling applications. 
• Allocate applications to reviewers for evaluation and follow-up thereof. 
• Identify schedules for substances, new chemical entities, authorised prescribers and update the schedules accordingly.
• Prepare a submission to the Minister of Health for approval of amendments of the schedules. 
• Support and prepare reports/documents for the Names and Scheduling Advisory Committee. 
• Referral of applications to various advisory committees and execution of recommendations thereof. 
• Responsible for updating standard operating procedures, templates, guidelines and applicable documents as per the defined processes. 
• Preparation of documents and presentations as requested by the Manager, Senior Manager, the Chief Regulatory Officer and the Chairperson of the committee. 
• Prepare, attend, and participate in discussions during meetings. 
• 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 Office of the Chief Regulatory Officer.