Manager: Biological Medicines

Requirements:

Matric certificate and a Bachelor of Pharmacy degree and NQF level 8 as recognised by the South African Qualifications Authority (SAQA) and a Master’s degree in pharmacy at NQF level 9. A post-graduate qualification in management would be advantageous. Proof of current registration with the South African Pharmacy Council (SAPC). A valid driver’s license is required. 

Experience:

A minimum of ten (10) years’ relevant experience in the medicines regulatory field in evaluating safety and efficacy for biological medicines, including product information and patient information leaflets, of which five (5) years must be at a supervisory/management level (Level 09 – 12) supporting business operations. Experience in the application of the Medicines and Related Substances Control Act 101 of 1965 (as amended), and its related Regulations. Knowledge of database management will be an added advantage. 

Competencies, Knowledge, and Skills:

• Knowledge of and experience with relevant national legislation, international standards, and best practices, e.g., IMDRF, WHO, AMDF, GHWP.
• Comprehensive knowledge and understanding of relevant legislation, protocols, standard operating procedures, and work instructions.
• Knowledge and application of the Medicines and Related Substances Act (101 of 1965) as amended and its related Regulations and Guidelines.
• Knowledge of technical aspects for the evaluation of quality, safety, and efficacy of medicines. Leadership skills.
• Preparation and management of strategic plans, business plans, and budgeting.
• Performance measurement skills.
• Diversity management.
• Time management.
• Technical and scientific aspects of medicine regulation.
• Self-motivated and able to work independently.
• Computer literacy and a sound working knowledge of computer software packages.
• Ability to manage a variety of cross- functional team members.
• Competent in problem-solving and team building.
• Information evaluation.
• Decision making.
• Objectivity.
• Resilience.
• Communication skills (verbal, written, negotiation, conflict management, presentation).
• Ethical behaviour.
• Planning and organising skills.
• Interpersonal skills.
• Assertiveness.