Medicine Registration Officer: Gr 2 (Clinical Pre-Registration Evaluations:Naming And Scheduling)

MEDICINE REGISTRATION OFFICER: GR 2 (Clinical Pre-registration Evaluations: Naming and SchedulingRef No.:SAHPRA/The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of theMedicines and Related Substances Act, , (Act No. of ) as amended,toprovide for the monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials and medical devices, and related matters in the public interest.REQUIREMENTS: Appropriate 4-year Bachelor of Pharmacy Degree and registration as a Pharmacist with the South African Pharmacy Council (SAPC). A relevant NQF 9 qualification in the health sciences will be an added advantage.EXPERIENCE: At least one year regulatory experience (post registration as a community pharmacist). Proof of registration as a Pharmacist must be submitted with your application.COMPETENCIES (KNOWLEDGE, SKILLS & ABILITIES):Knowledge and application of the Medicines and Related Substances Control Act of , as amended, and its related Regulations, with respect to the regulation of medicines in terms of quality, safety, and efficacy. Computer literacy (MS Office packages). Supervisory skills. Good planning, organisational and interpersonal skills. Good communication skills (written and verbal). Innovative thinking, initiative, and leadership qualities. Dedication and accurate work. Knowledge of database management will be advantageous. Must be willing to travel and work irregular hours.A valid drivers licence.DUTIES:Process the naming and scheduling of new chemical entities. Allocate new registration applications to reviewers. Identify substances, new chemical entities and update the Schedules, accordingly. Evaluation of generic PI/PIL applications (new applications and responses). Follow-up with evaluators regarding applications allocated. Prepare reports/documents for the Advisory Naming and Scheduling Committee. Support the Expert Naming and Scheduling Committee. Capturing the Advisory Clinical Committee minutes and recommendations. Execution of Advisory Clinical Committee recommendations. Ensure the correctness of Advisory Clinical Committee recommendations. Preparation of urgent documents as requested by the Manager, Senior Manager, the Chief Regulatory Officer, and the Chairperson of committee. Assist in finalization of the committee meeting agenda. Prepare, attend, and participate in discussions during the 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 Chief Regulatory Officers Office.INSTRUCTIONS TO APPLICANTS:All applications must:Be submitted with a covering letter clearly reflecting thename of the position and post reference number, be signed, accompanied by a comprehensive CV, the names of 3 referees and recently certified copies of ID and qualification/s.Applications without the afore mentioned will not be considered. Should you be in possession of a foreign qualification, it must be accompanied by an evaluation certificate from the South African Qualification Authority (SAQA).A separate application must be completed for each post. SAHPRA will not be liable where applicants use incorrect or no reference number on their applications.Applications must be submitted by email ******, including the required certified documentation as indicated.DO NOT MAKE ENQUIRIES TO THIS ADDRESS.No late applications will be accepted. CVs will not be returned. Applications, which are received after the closing date and time, will not be considered.Further communication will be limited to shortlisted candidates. If you have not received a response from SAHPRA within 3 months of the closing date, please consider your application as unsuccessful.It will be expected of candidates to be available for selection interviews on a date, time and place as determined by SAHPRA.Applicants must note that further checks will be conducted once they are shortlisted and that their appointment is subject to positive outcomes on these checks, which include security clearance, qualification verification, criminal records, credit records, citizenship status and previous employment.SAHPRA is guided by the principles of Employment Equity. Candidates with disabilities are encouraged to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill or not to fill the vacant post/s.Enquiries: Ms S. Molepo. Email: ****** (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS).Back to Vacancies Download Advert
Pretoria, GT, ZA