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Senior Regulatory Affairs Associate

4 months ago

Bloemfontein, South Africa Parexel Full time

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. Aa s 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 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.