Senior Regulatory Affairs Associate – Clinical Trial Applications

Responsibilities

• Ensure timely performance of work within project scope to quality expectations of internal stakeholders and clients
• Act as Project Lead or Work Stream Lead
• Assure the work of the team is delivered on time and meets clients’ quality expectations
• Manage local submissions as Local Regulatory Contact (LRC)
• Coordinate regulatory submissions in participating countries as Regulatory Lead
• Participate in Regulatory Operations meetings, project team meetings
• Maintain relationships with other departments, clients, and regulatory agencies
• Involve in local, regional, and/or global projects

Requirements

• University degree in a science discipline
• Background in clinical trial management
• Initial years of Regulatory Affairs experience working with Clinical Trial Applications in South Africa - must
• Experience with clinical trial submissions in other Southern African Countries - preferred
• Good level of knowledge of the CTA business
• Expertise/skill in cross-functional project management and planning
• 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.