Senior Regulatory Affairs Associate – Clinical Trial Applications

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Ensure timely performance of work within project scope to quality expectations of internal stakeholders and clients • Act as Project Lead or Work Stream Lead • Assure the work of the team is delivered on time and meets clients’ quality expectations • Manage local submissions as Local Regulatory Contact (LRC) • Coordinate regulatory submissions in participating countries as Regulatory Lead • Participate in Regulatory Operations meetings, project team meetings • Maintain relationships with other departments, clients, and regulatory agencies • Involve in local, regional, and/or global projects

🎯 Requirements

• University degree in a science discipline • Background in clinical trial management • Initial years of Regulatory Affairs experience working with Clinical Trial Applications in South Africa - must • Experience with clinical trial submissions in other Southern African Countries - preferred • Good level of knowledge of the CTA business • Expertise/skill in cross-functional project management and planning • 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.

🏖️ Benefits

• Health insurance • Flexible working arrangements • Professional development opportunities