I am a B.Pharm educated Regulatory Affairs Professional with extensive experience in regulatory affairs, quality assurance, quality management systems, product lifecycle management and continuous improvement. I have worked as a licensed Pharmacist in both South Africa and the United Kingdom. As a Regulatory Affairs Professional, I place a high priority on establishing and maintaining Quality Management System (QMS) Principles, including leadership, evidence-based decision making, continuous improvement, customer focus, engagement of people and relationship management. I am a team-professional, highly focused to succeed and contribute to the organization I represent, the teams that I form part of, as well as my customers. I have a strong personal values system based on continued learning, personal growth, and professional development. Key Competencies: CTD/eCTD compilation, variations, and renewals. Conversion of existing submissions to CTD/eCTD format. Marketing authorization applications in South Africa, Sub-Saharan Africa, East and West African countries, including Botswana, Ghana, Kenya, Mauritius, Madagascar, Namibia, Nigeria, Tanzania, Uganda, Zambia, Zimbabwe. Product compliance activities (through the product lifecycle) for Regulated Markets. Establishment license applications: Marketing Authorization Holders of Drug Products, Medical Devices and Medicinal Cannabis Products (incl. Cultivation, Harvesting and Manufacturing activities). ISO 13485:2016 Medical Devices: Internal Auditor Third-party audits and preparations for Regulatory Authority inspection readiness (GMP, GDP, ISO). Quality Assurance and Quality Management System implementation and management. Management of Product Complaints, Adverse Drug Reactions, Adverse Events & Pharmacovigilance activities. Training of personnel on SOPs and related processes pertaining to activities of RA/QA/QMS. Key Achievements: CEO Award, Cipla South Africa, July 2012 In recognition of excellence in Regulatory Affairs and Project Management. Managed Cipla’s successful new product development and manufacture of Entiro™ Probiotic Capsules in collaboration with Bifodan A/S, Denmark and Professor Leon Dicks, researcher and developer from the Department of Microbiology at the Stellenbosch University.