The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances,...
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Medicine Registration Officer: Names and Scheduling
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.
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