Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are looking for an experienced Senior Regulatory Affairs Professional 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 may act as a Project Lead or Work Stream Lead and in this role you will assure the work of the entire team or work stream 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 able to coordinate the regulatory submissions in all participating countries as Regulatory Lead.
- 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/skill in cross-functional project management and planning, process optimization
- IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
- Solid analysis and synthesis capability; Solution-oriented and problem-solving skills.
- Customer-oriented and autonomous
- Fluency in English is a must along with the local language.