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 Consultant – 新薬開発計画CMC薬事
🕒 December 12, 2025
🗣️🇯🇵 Japanese Required
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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
• CMC薬事戦略策定及び製造販売承認申請業務 • クライアントとの協議、交渉実施 • 薬剤開発におけるCMC申請資料作成支援
🎯 Requirements
• 3年以上のCMC薬事経験 • 製剤開発もしくは分析研究等のCMC研究経験 • 製造販売承認申請書作成の経験 • 生物製剤に関するCMC経験者尚可 • 大学卒（薬学もしくは自然科学分野） • 英語での業務上のコミュニケーションが可能（TOEIC 700目安）
🏖️ Benefits
• Health insurance • Remote work options
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