We are looking for a Senior Regulatory Affairs Associate with working knowledge of Clinical Trial Applications (CTA) to join our team in South Africa! This role can be office-based (Bloemfontein) or home-based anywhere in South Africa.
As a Senior Regulatory Affairs Associate, you will ensure the timely performance of work within a project scope to the quality expectations of internal stakeholders and clients. You will bring your specialist knowledge of clinical trial submissions in Sub-Saharan countries. As a Senior Associate, under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed and delivered on time, meeting the quality expectations of Parexel and our clients. You may take up a client-facing role with support from line management.
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 Trial 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.
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