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.
CMC Regulatory Affairs Associate, M3 Authoring Experience for Biological Products
🕒 June 24
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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
• Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs • Prepare and review CMC packages • Support GMP submissions • Manage change control assessments • Ensure compliance with regulatory requirements across multiple regions • Collaborate with project SMEs and client stakeholders to prepare submission packages • Act as main GRA point of contact for LRAs and other stakeholders
🎯 Requirements
• A degree in biological or health sciences (Regulatory Affairs preferred) • At least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry • Strong technical regulatory expertise • Excellent writing skills • Ability to evaluate scientific CMC information for accuracy
🏖️ Benefits
• Competitive salary • Flexible working hours • Professional development opportunities • Work from home options
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