South Africa Job Openings
Parexel
Senior Regulatory Affairs Associate - CTA
Bloemfontein
November 26, 2024
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:
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Manage the local submissions (as Local Regulatory Contact - LRC)
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Coordinate the regulatory submissions in all participating countries as Regulatory Lead.
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Regulatory submission of Clinical Trial in the region
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Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
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You may lead or be involved in local, regional, and/or global projects
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Guide and mentor junior team members
Skills and Experience required for the role:
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University degree in a science discipline
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Background in clinical trial management
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3-5 years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa
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Experience with clinical trial submissions in other Southern African Countries
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IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – power BI)
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Customer-oriented and autonomous
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Fluency in English is a must along with the local language.
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