Senior Regulatory Scientist

• Lead or significantly contribute to regulatory strategy development for clinical programmes and key milestones
• Author and review complex regulatory documents, including clinical trial applications, briefing documents, and major submission components
• Interpret global regulations, guidelines, and precedents and advise cross-functional teams on regulatory expectations and risk
• Participate in or lead health authority interactions, including meeting preparation, presentation support, and follow-up
• Provide regulatory input into clinical development plans, risk management strategies, and labelling considerations
• Mentor junior regulatory staff and contribute to internal standards, templates, and best practices
• 薬事関連資料（各種面談資料、治験届等）の作成
• 当局との連携・新薬申請から承認取得までの各種対応・進捗管理
• 社内他部門との連携と薬事観点のアドバイス提供
• 薬事戦略の提案やプレゼンテーション
• 新規事業獲得にむけてクライアントへのアプローチ
• CMC関連文書作成・CMCコンサルティング全般
• 業務関連通知・規制アップデートの全体共有
• Managerと複数名のチームを組んで業務プロジェクトに対応

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Substantial experience in regulatory affairs or regulatory science within pharma, biotech, or CRO
• Strong understanding of global clinical development regulations and guidance, including FDA, EMA, and ICH
• Excellent scientific writing, analytical, and critical-thinking skills, with meticulous attention to detail
• Proven experience supporting or leading health authority interactions and complex submissions
• Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams
• Willingness to travel as required, approximately 5%
• 3年以上の規制当局との折衝やコミュニケーション、円滑なやり取りなどの実務経験
• 英語でのコミュニケーションスキル、文書作成能力
• 言語ビジネスレベルの英語力
• Microsoft Word / Excel / PPTを業務で使用できること
• Copilotを使用した文献調査の経験があれば尚良し

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways