Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)

Parexel is seeking an experienced Senior Regulatory Affairs Professional with knowledge of Clinical Trial Applications (CTA) to join their team in South Africa. The role involves managing regulatory submissions, acting as a project lead, and ensuring compliance with quality standards, either office-based in Bloemfontein or remote anywhere in South Africa.

Location: South Africa (office-based in Bloemfontein or remote)

Responsibilities

• Manage the local submissions as Local Regulatory Contact (LRC) and coordinate 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.
• Involvement 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.
• Experience with clinical trial submissions in other Southern African Countries (preferred).
• Good knowledge of the CTA business, cross-functional project management, planning, and 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 and the local language.