Senior Regulatory Affairs Associate - CTA at PAREXEL

Key Deliverables in the role:

• Manage the local submissions (as Local Regulatory Contact - LRC)
• Coordinate the regulatory submissions in all participating countries as Regulatory Lead.
• Regulatory submission of Clinical Trial in the region
• ​​​Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
• You may lead or be involved in local, regional, and/or global projects
• Guide and mentor junior team members

Skills and Experience required for the role:

• University degree in a science discipline
• Background in clinical trial management
• 3-5 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
• Experience with clinical trial submissions in other Southern African Countries
• IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
• Customer-oriented and autonomous
• Fluency in English is a must along with the local language.