Senior Manager: Inspectorate and Regulatory Compliance 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.