Key Deliverables in the role:

• Manage the local submissions (as Local Regulatory Contact – LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead.
• Regulatory submission of Clinical Trial in South Africa
• ​​​Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
• You may be involved in local, regional, and/or global projects

Skills and Experience required for the role:

• University degree in a science discipline
• Background in clinical trial management
• 1-2 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
• Experience with clinical trial submissions in other Southern African Countries – preferred
• Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
• IT knowledge (Veeva Regulatory and Clinical Vaults – excel – VBA – powerBI)
• Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.
• Customer-oriented and autonomous
• Fluency in English is a must along with the local language.