Senior Regulatory Affairs Associate – Clinical Trial Applications

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Ensure the timely execution of tasks within the project scope, meeting the quality standards set by internal stakeholders and clients.

• Serve as the Project Lead or Work Stream Lead.

• Guarantee that the team's output is delivered punctually and aligns with the quality expectations of clients.

• Oversee local submissions in the role of Local Regulatory Contact (LRC).

• Coordinate regulatory submissions in participating countries as the Regulatory Lead.

• Participate in Regulatory Operations meetings and project team discussions.

• Foster relationships with other departments, clients, and regulatory agencies.

• Engage in local, regional, and/or global projects.

⛳️ Requirements

• A university degree in a scientific field.

• Experience in clinical trial management.

• A few years of experience in Regulatory Affairs, specifically with Clinical Trial Applications in South Africa - required.

• Familiarity with clinical trial submissions in other Southern African countries - preferred.

• A solid understanding of the Clinical Trial Application (CTA) process.

• Proficiency in cross-functional project management and planning.

• IT skills, including knowledge of Veeva Regulatory and Clinical Vaults, Excel, VBA, and Power BI.

• Strong analytical and synthesis capabilities.

• Solution-driven with effective problem-solving skills.

• Customer-focused and self-reliant.

• Proficiency in English is essential, along with the local language.

🏝️ Benefits

• Health insurance.

• Flexible working arrangements.

• Opportunities for professional development.