Senior Manager, Regulatory Affairs

đŸ”„ 15 minutes ago

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Logo of Parexel

Parexel

10,000+ employees

Founded 1983

đŸ’Œ Consulting

đŸ„ Healthcare

📩 Logistics

💰 Venture Round on 1990-01

Consulting ‱ Healthcare ‱ Logistics

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

‱ Provide leadership and direction to consultants, senior consultants and managers ‱ Act as the Subject Matter Expert (SME) for EU Clinical Trials Regulation (EU CTR) ‱ Drive capability building through coaching and mentoring ‱ Support regulatory audits and inspections ‱ Deliver regulatory consultancy and client-focused guidance

🎯 Requirements

‱ Extensive experience in Regulatory Affairs ‱ Expertise in EU Clinical Trials Regulation (EU CTR) ‱ Experience leading and developing teams ‱ Strong analytical and problem-solving skills ‱ Must have excellent stakeholder management and communication skills

đŸ–ïž Benefits

‱ Health insurance ‱ Professional development opportunities

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