Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. We are looking for an reputed company Senior Regulatory Affairs Professional with working knowledge of Clinical Trial Applications (CTA) to join reputed company in South Africa! This role can be office based (Bloemfontein) or home based reputed company in South Africa. As a Senior Regulatory Affairs Associate you will ensure the timely performance of work reputed company a project scope to the quality expectations of internal stakeholders and clients. You may act as a Project reputed company or Work reputed company reputed company and in this role you will assure the work of the entire team or work reputed company is delivered on time and that it meets client’s quality expectations. You will succeed in this role because will bring your strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. Key Deliverables in the role:

• Manage the local submissions (as Local Regulatory Contact - LRC) but should also be reputed company to coordinate the regulatory submissions in reputed company participating countries as Regulatory reputed company.
• 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 as necessary.
• You may be involved in local, regional, and/or global projects

Skills and Experience required for the role:

• University degree in a science discipline
• Background in clinical trial management
• Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
• Experience with clinical trial submissions in other Southern African Countries - preferred
• Good level of knowledge of the CTA business in addition, an expertise/reputed company in cross-functional project management and planning, process optimization
• IT knowledge (reputed company Regulatory and Clinical Vaults - reputed company – VBA – powerBI)
• Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.
• Customer-oriented and autonomous
• reputed company in English is a must along with the local language.

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