SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) VACANCIES

 
 
PROGRAMME MANAGER: BACKLOG CLEARANCE PROJECT 
Ref No.: SAHPRA 016/2022 
(Fixed Term Contract Until 31 December 2022) 
SMS LEVEL 14 
CENTRE: Pretoria 
 
REQUIREMENTS:
• Appropriate 4-year Bachelor of Pharmacy Degree or BSc in a Biological Science or equivalent 
• Registration with SAPC or HPCSA 
• A Post graduate degree in Pharmaceuticals, Pharmacology, or other relevant science degree, complemented by a Project Management qualification 
• At least 8- 10 years’ experience in health products regulation 
• Proven 5-7 years working experience in high pressure roles/ environment 
• 5-7 years of project management experience including managing teams, developing and evaluating budgets, creating and implementing work plans, and monitoring both project and staff performance 
• Knowledge of Medicines and Related Substances Act and health products regulation 
• Proven knowledge of project management, including managing teams, developing and evaluating budgets, creating and implementing work plans, and monitoring both project and staff performance 
 
SKILLS:
• Strong analytical skills and leadership skill with a proven track record of integrity and successful implementation of projects 
• Display exceptional stakeholder management capabilities 
• Ability to communicate fluently in English with both written and verbal communication 
• Defines and prioritizes goals, thereby achieving business objectives 
• Good decision-making ability 
• Critical thinking and problem-solving skills 
• Planning and coordination skills 
• Ability to manage conflict 
• Ability to tolerate stress 
 
DUTIES:
• Ensure achievement of Backlog Clearance Project deliverables by set deadline 
• Develop, implement, and monitor the Backlog Clearance Program project plan within the set timelines. 
• Ensure appropriate operating, monitoring, and reporting tools and systems are in place to support the Backlog Clearance Project (e.g., IT systems, etc.). 
• Identify and problem-solve obstructions in the project workflow and recommend and implement process improvements 
• Ensure robust tracking and reporting of project progress; ensure coordination and implementation of identified tasks / process improvements 
• Oversee recruitment, on-boarding, and training (including ongoing training) of Backlog Clearance Project staff 
• Lead and manage Backlog Clearance Project team; ensure performance management measures are in place and achieved 
• Communicate progress on key milestones and key updates to SAHPRA executive management and Board, as well as Industry 
• In collaboration with other SAHPRA managers and team members, facilitate the integration of Backlog processes and personnel into BAU upon completion of the Backlog Clearance Project. 
• Manage funder grants responsibly and effectively. 
• In collaboration with the SAHPRA CFO, report on Backlog Clearance project funding to the relevant funders, as well as SAHPRA EXCO and Board. 
• Regular reporting to funder regarding the progress within the Backlog Clearance Project
 
 
INSTRUCTIONS TO APPLICANTS: All applications must: 
• Be submitted with a covering letter clearly reflecting the name 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 to recruitment@sahpra.org.za, including the required certified documentation as indicated. DO NOT MAKE ENQUIRIES TO THIS ADDRESS.
• No late or faxed applications will be accepted. CV’s will not be returned. Applications, which are received after the closing date, 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: Email: matshepo.mokotong@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS). 
 
CLOSING DATE: 21 March 2022 at 16H00.

MEDICAL OFFICER: GR 2 
(Clinical Evaluation Management: Section 21 Unit) 
(DPSA Equivalent Level OSD TCE: GR 2 – R953 049) 
Ref No.: SAHPRA 015/2022 
CENTRE: Pretoria 
 
REQUIREMENTS: • MBBCH qualification that allows registration with the Health Professions Council of South Africa (HPCSA) as a Medical Practitioner (Independent Practice). • Certification of Registration with the HPCSA (proof of current annual registration) must be submitted with the application. 
 
Experience: • Previous regulatory affairs/clinical pharmacology/clinical research experience will be an added advantage. 
 
COMPETENCIES, KNOWLEDGE AND SKILLS: * Sound and in-depth knowledge of the Medicines and Related Substances Act 101, 1965 as amended and the regulations pertaining to the Act. * Sound knowledge of regulatory scientific and technical requirement (in terms of quality, safety and efficacy aspect). * Good knowledge of the regulatory requirements of the use of an unregistered medicine, i.e., Section 21 of the Medicines Act and Regulation 29 of the General Medicines Regulations. * Comprehensive knowledge and understanding of the international regulatory clinical trials guidelines. * Computer skills (Knowledge of MS Office). * Planning and organising skills. * Drive and self-management skills. * Communication skills (verbal, written, negotiation, conflict management, presentation). * Ability to work in a highly pressured environment and driven by a sense of urgency to meet deadlines.* Assertiveness. * Ethical behaviour. * Prepared to travel and work irregular hours. *A valid driver’s licence. 
 
DUTIES: * Technical screening of section 21 applications. * Evaluation of Section 21 applications. * Research Section 21 applications for new unregistered medicines. * Liaise with experts on high-priority applications. * Attend to and review written Section 21 queries, e.g., procedural, new products, monitor Section 21 email inbox. * Compile Section 21 agenda documents for presentation at Clinical Trials Committee meeting or SAHPRA internal discussions. * Prepare minutes of the CTC meeting pertaining to Section 21 resolutions. * Prepare letter/s to relevant stakeholders communicating CTC meeting resolutions or expert discussion on Section 21 issues. * Conduct monitoring and evaluation of the unit’s activities as per Annual Performance Plan, Operational Plan, revenue-generating requirements and risk register entries on a monthly and quarterly basis. * Supervise admin staff in the Section 21 unit. * Draft policy documents as pertains to section 21 authorizations (SOPs, guidelines, legislation amendments). * Contribute to optimal submission of proof of payment source document (section 21 applications) to the Finance unit. * Liaise with experts on high-priority applications. * Play an active role with stakeholder engagement, awareness and outreach programs (e.g., applicants, pharmaceutical industry, NDoH, etc.). 
 
 
INSTRUCTIONS TO APPLICANTS: All applications must: 
• Be submitted with a covering letter clearly reflecting the name 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 aforementioned documents/information 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 to recruitment@sahpra.org.za, 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, 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: setlola.molepo@sahpra.org.za (DO NOT SEND APPLICATIONS TO THIS EMAIL ADDRESS). 
 
CLOSING DATE: 18 March 2022 at 16H00.