Regulatory CMC Scientist


JoB No. 205

業種 製薬メーカー

ポジション名 Regulatory CMC Scientist

職種 薬事

業務内容 • In charge of executing Japan RA strategies for CMC in line with UCBJ/ the UCB global RA strategy under manager’s supervising
• Implement/ Ensure the application dossier for the NDA and approval
• In charge of submission of Pre-approval GMP inspection under manager’s supervising
• Ensure quality of the regulatory documents according to UCB quality standards
• Assess or recommend solution/ prevention plans for issues related to the import, manufacture, and sales of market products
• Supports to resolve/ prevent problems related to the import, manufacture, and sales of market products
勤務地 東京都

応募資格 • Minimum 3 years of experience within the pharmaceutical industry
• Minimum 1 years of experience in regulatory affairs, CMC section in laboratory or quality control within the pharmaceutical industry
• International collaboration preferred
• Demonstrated ability to develop and manage regulatory agency relationships
• Hand-on experience in some phases of regulatory process, content expert in one or more areas of product development and life-cycle
• Self starter

雇用形態 正社員

年収目安 ~1,000万(経験・スキルによる)

備考 ---
担当コンサルタント 小川 善之