SKILLS & QUALIFICATIONS:

• Bachelor’s degree in Pharmacy, registered with the South African Pharmacy Council
• MSc, MBA or PhD may be an advantage.
• Experience in regulatory affairs, preferably in human medicines – minimum 8 years of experience.

Key Knowledge and Skills required:

• Experience in registration of products and regulatory knowledge on South Africa, Botswana and Namibia market guidelines.
• Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
• Proven ability to manage complex Regulatory issues and consistently deliver to time, cost and quality standards.
• Regional Regulatory experience including knowledge of NDA, multisource product applications, and product lifecycle management processes.
• Demonstrate experience of effective delivery in a complex matrix environment.
• Knowledge of Regional Regulatory environment
• Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
• Knowledge of drug development, regulations and guidelines
• Strong leadership and management qualities, including excellent communication, negotiation, and interpersonal skills
• Understanding of pharmaceutical industry, clinical trials and pharmacovigilance
• Knowledge and understanding of quality systems, processes, audit and inspection