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). A management qualification (MBA/MBL/MAP) or similar qualification will be an added advantage. A valid driver’s license 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). 

Required Competencies (Knowledge, Skills and Abilities) 

• Good understanding of the pharmaceutical industry in South Africa is required.
• Detailed knowledge of various international standards and norms on the quality aspects of medicines.
• Good understanding of concepts of quality management systems.
• Knowledge of complaint management system.
• Knowledge of various pharmaceutical marketing codes.
• Knowledge of budgeting and financial management system.
• Sound knowledge of medicine registration concerning safety, quality and efficacy of medicines.
• Familiarity with ICH and WHO technical guidelines required.
• Broad knowledge of the Public Finance Management Act, 1999 (Act 1 of 1999) (PFMA) and its regulations, the Labour Regulations Act, 1995 (Act 66 of 1995) and the Employment Equity Act, 1998 (Act 55 of 1998).
• Exposure to the evaluation of applications for registration of new chemical entities and generic applications will serve as an advantage.
• Good understanding of Post-Marketing Surveillance.
• General management, budgeting and financial management skills.
• Good planning, organisational, and presentation skills.
• Performance measurement skills.
• Excellent communication skills (verbal, written, influencing, conflict management, presentation) and interpersonal skills.
• Research and investigation.
• Analytical and report writing skills.
• Computer skills.
• Resilience and ethical behaviour.
• Must be willing to travel and work irregular hours.