Takalani Nemakonde

I'm a detail-oriented and results-driven Regulatory Affairs Officer with over 5 years of hands-on experience in Regulatory Affairs, Quality Assurance, and Quality Control, particularly in the pharmaceutical and animal health sectors. I've built a solid reputation for compiling CTD dossiers, managing regulatory submissions across SADC countries like BOMRA and ZAMRA, and ensuring compliance after registration. I've successfully set up and maintained strong Quality Management Systems (QMS) that align with ISO 9001:2015 and GMP standards, which led to our certification. I also conduct internal audits, manage CAPAs, and spearhead cross-functional quality improvement initiatives. I'm truly passionate about operational excellence, regulatory compliance, and nurturing a culture of continuous improvement. A quote that resonates with me is from Alvin Toffler: "You've got to think about the big things while you're doing the small things so that all the small things go in the right direction." This philosophy shapes my approach to balancing immediate tasks with long-term objectives, emphasizing my commitment to continuous improvement, strategic planning, and effective execution.

• Advanced Diploma in Pharmaceutical Science, 01/01/25, Tshwane University of Technology (TUT)
• Led the implementation team to successfully achieve ISO 9001:2015 certification, 10/01/24
• ISO 9001:2015 Internal auditor, 01/01/24
• Completed a short course in Regulatory Affairs, 01/01/23, Pharmers Academy
• Obtained a National Diploma in Analytical Chemistry, 01/01/15, Vaal University of Technology