Parexel
10,000+ employees
Founded 1983
💼 Consulting
🏥 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.
Senior Regulatory Affairs Consultant
🕒 June 24
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Parexel
10,000+ employees
Founded 1983
💼 Consulting
🏥 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
• Contribute to preparation and delivery of regulatory submissions from a global and regional perspective • Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia • Guide/mentor team members on technical aspects including regulatory filings to global markets
🎯 Requirements
• 10 to 14 years of relevant experience • Minimum of a bachelor’s degree in a Scientific or Technical Discipline • Extensive experience in managing new registrations, life cycle maintenance, and renewals for biological products • Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules • Strong communication and collaboration skills • Ability to work independently
🏖️ Benefits
• Flexible work arrangements
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