Jobs Available at South African Health Products Regulatory Authority

REQUIREMENTS: 

• Matric certificate, Pharmacy degree/Registration as a Pharmacist with the South African Pharmacy Council (SAPC).
• Post-graduate qualification in Pharmaceutical or Scientific Master’s degree at NQF level 9 as recognised by the South African Qualifications Authority (SAQA).
• management qualification (MBA/MBL/MAP) or similar qualification will be an added advantage. A valid driver’s licence is also required. 

EXPERIENCE: 

• A least 10 years’ relevant experience in the medicines regulatory field, of which five (5) years must be at a management level (level 12 – 13) supporting business operations. Two (2) years at senior management level (level 13 – 14) will be an added advantage.
• Extensive knowledge and application of the Medicines & Related Substances Act (Act 101 of 1965) and its Regulations, Hazardous Substances Act 1973, National Health Act 2003, and working knowledge of the Criminal Procedure Act.
• Extensive knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Wholesaling Practice (GWP), Good Clinical Practice (GCP), Good Vigilance Practice (GVP) and Good Distribution Practice (GDP).

DUTIES: 

• Develop and coordinate systems for management of all operations of the Regulatory Compliance and Inspectorate Programme. Develop a strategy, an annual performance plan, operational plans and budget for the program aligned with organisational needs and ensuring the most effective utilisation of resources.
• Contribute as a member of the senior management team responsible for strategic and operational planning of the organisation in order to ensure the achievement of organisational objectives and meet the needs of all stakeholders.
• Prepare monthly, quarterly and annual reports for work done within the Programme including monitoring of the timelines.
• Directs the enforcing of relevant legislation by overseeing the monitoring and managing the importation and use of narcotic drugs; the legal handling, product recalls, sale and advertisement of medicines, the investigation of alleged counterfeiting of medicines, the execution of inspections (GMP, GCP, GWP, GLP, GVP and GDP).
• Oversees preparation and endorses reports to be submitted to relevant advisory committee for their information, discussion, review and/or recommendation in accordance with prescribed legal requirements and standard operating procedures of SAHPRA.
• Oversees the effective, timeous communication and consulting thereon regarding issues relating to inspections, regulatory compliance and licensing in order to guide public health and other authorities on appropriate policies and interventions.
• Oversees the development, implementation and maintenance of regulations, guidelines, policies and procedures pertaining to regulatory compliance, inspections, licensing and laboratory services to ensure alignment with international and national protocols, legislations and other legal requirements.
• Liaises with representatives from industry and international regulators, law enforcement agencies and other relevant stakeholders to ensure appropriate and correct information and establishment of productive and relevant relationships.
• Ensure active and meaningful participation by South African regulatory functions in the global arena.
• Oversees compliance to service level agreements with outsourced support services such as laboratories to ensure achievement of agreed quality and delivery standards.
• Train and manage managers reporting to this role to ensure they have the skills required by the organisation and are able to achieve their performance objectives. Ensure that a high level of integrity is maintained by staff members by promotion of high ethical conduct and maintaining high-performance standards.
• General financial budgeting, human resources and performance management. Perform such other functions as the Chief Regulatory Officer or the Chief Executive Officer may duly allocate or delegate from time to time.

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REQUIREMENTS: 

• Applicants must have a Matric certificate and an appropriate four-year Bachelor of Pharmacy degree and registration as a pharmacist with the South African Pharmacy Council (SAPC) at NQF Level 8 as recognised by the South African Qualifications Authority (SAQA) or an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA. A relevant Master’s qualification at NQF Level 9 as recognised by SAQA will be an added advantage. A valid driver’s licence is required. 

EXPERIENCE

• Grade 1: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC, plus a minimum of three (3) years’ regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance; OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of five (5) years’ regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 
• Grade 2: Four-year Bachelor of Pharmacy degree at NQF Level 8 as recognised by SAQA and registration as a pharmacist with the SAPC plus a minimum of five (5) years’ regulatory experience (post community service) in pharmaceutical or related medicines regulation or medicine production quality assurance OR an Honours degree in related health sciences at NQF Level 8 as recognised by SAQA plus a minimum of eight (8) years regulatory experience in pharmaceutical or related medicines regulation or medicine production quality assurance. 

DUTIES: 

• Evaluation of new applications and peer reviewing of new applications: Generate evaluation report(s) for each new application (new chemical entities (NCE) and Generics) in compliance with the required template and adopted regulatory/scientific standards and submit for peer review. Following the peer-review process, amend the report(s) accordingly to generate a list of queries to the applicant using the correct templates. Peer review primary report(s) compiled by other reviewers. Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. Prepare query letters for applicants. Prepare a basis for approval or rejection. Provide quality assurance of reports and facilitate resolutions on technical matters. 
• Evaluate applicant responses for registration/approval of medicines: Generate second (and subsequent) evaluation reports for each response application and submit for peer-review in compliance with required template and adopted regulatory/scientific standards and submit for peer review. Following the peer-review process, amend the report accordingly to generate a list of queries to the applicant, if necessary. Peer review other evaluators’ response reports, according to the required template and adopted regulatory/scientific standards. Prepare reports for the internal working groups and, where necessary, present at the advisory committee for complex scientific matters. Prepare query letters to applicants. Prepare a basis for approval or rejection. Provide quality assurance of reports and facilitate resolutions on technical matters. 
• Technical screening for the quality and efficacy (bioequivalence) aspects of new applications for the registration of medicines: Generate technical screening evaluation reports for each application and submit for peer review. Following the peer-review process, amend the technical screening reports accordingly to generate a list of queries to the applicant using the correct templates. Peer-review technical screening reports compiled by other reviewers. Prepare screening query/screening rejection letters to applicants. Provide quality assurance of reports and facilitate resolutions on technical matters. 
• Develop and update guidelines, SOPs and templates: Review existing guidelines, standard operating procedures (SOPs) and templates and update when necessary. Provide training on guidelines, SOPs and templates. Create new guidelines, SOPs and templates where relevant. Provide regular work plans and output to the unit manager (qualitative and quantitative report). Perform any other related duty as requested by the manager/senior manager. 
• Form part of technical working groups or special projects and also provide support to the unit as well as to advisory committees: Participate in special projects and registration groups. Lead and manage assessments peer-review and discussion working groups, where relevant. Compile discussion documents and reports. Provide regular training to new internal medicine registration officers (MROs) and external evaluators. Take comprehensive notes of discussions of relevant discussions. Prepare documents for the SAHPRA management/RC meetings. 
• Risk Management and Audit: Adhere to SOPs and guidelines. Create and maintain databases. Use the most current templates and guidelines. Provide and attend relevant training as may be necessary. Align with Quality Management System requirements. Align with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, World Health Organisation, International Pharmaceutical Regulators Programme and other international standards.