Parexel
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.
Senior Regulatory Affairs Associate – Clinical Trial Application
🔥 0 minutes ago
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Parexel
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
• Lead end-to-end CTA project management across multiple studies and countries • Plan, track, and deliver submissions aligned with timelines and regulatory requirements • Manage risks, dependencies, and complexities in global regulatory environments • Apply knowledge of EU CTR and ROW CTA requirements • Manage core clinical and regulatory documentation • Collaborate with cross-functional global teams • Build and maintain stakeholder relationships and resolve conflicts • Monitor KPIs related to timelines and deliverable quality • Identify risks and lead quality investigations as needed
🎯 Requirements
• Bachelor’s degree in Life Sciences, Pharmacy, or related field • Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar • Experience in Clinical Trial Application submissions (EU CTR & ROW) • Strong project management experience in a global/matrix environment • Familiarity with clinical trials and regulatory processes
🏖️ Benefits
• Remote working arrangements • Opportunities for professional development
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