Description
Group Purpose
To support the Regulatory Support Excellence function by ensuring high-quality, consistent, and efficient execution of Japan Regulatory operations, enabling reliable delivery across regulatory activities.
薬事本部全体の業務実行を支える基盤として、品質・一貫性・効率性の高い薬事オペレーションを実務面から支援する。
Job Summary
The Senior Associate, Regulatory Support Excellence supports the day-to-day execution of regulatory operational processes, documentation, and governance under the direction of the Sr. Manager.
This role works in close collaboration with Regulatory Assistants, coordinating and overseeing routine operational activities to ensure tasks are executed accurately, on time, and in alignment with defined processes.
The position focuses on disciplined execution, process adherence, and effective task orchestration to enable consistent, high-quality regulatory delivery.
薬事サポートエクセレンス – シニアマネジャーの指示のもと、薬事業務の実行、オペレーション、ガバナンスを日常的に支援する。
薬事アシスタントと連携し、定型的なオペレーション業務を調整・管理することで、業務が定義されたプロセスに沿って正確かつ期限通りに遂行されるよう担保する。
本ポジションは、実行の規律、プロセス遵守、業務の適切な差配を通じて、薬事業務の一貫性と品質を支える役割を担う。
Key Activities
**Regulatory Operations Support**
+ Execute standardized regulatory operational processes across submissions, reviews, and post-approval activities in alignment with defined workflows
+ Coordinate day-to-day regulatory operational tasks in collaboration with Regulatory Assistants to ensure timely and accurate execution
+ Review outputs prepared by Regulatory Assistants to ensure completeness, accuracy, and adherence to agreed standards
+ Maintain high-quality regulatory documentation and records through disciplined execution
+ 定義された業務フローに基づき、申請、審査対応、承認後業務における薬事オペレーションを実行
+ 薬事アシスタントと連携し、日常的なオペレーション業務の調整・差配を行い、期限内かつ正確な実行を担保
+ 薬事アシスタントが作成・対応した成果物をレビューし、完全性・正確性・基準遵守を確認
+ 規律ある実行を通じて、高品質なRegulatoryドキュメントおよび記録を維持
**Process & Governance Execution**
+ Support implementation and consistent application of SOPs, operational standards, and RACI across regulatory activities
+ Monitor execution against defined processes, identifying gaps or deviations and escalating issues as appropriate
+ Reinforce process discipline within the operational team, including Regulatory Assistants, to ensure sustainable execution
+ SOP、業務標準、RACIの実装および一貫した運用を支援
+ 定義されたプロセスに対する実行状況をモニタリングし、課題や逸脱を検知・適切にエスカレーション
+ 薬事アシスタントを含むオペレーションチーム内でのプロセス規律を定着させ、持続可能な業務遂行を支援
**Task Coordination & Workload Management**
+ Plan, prioritize, and coordinate operational tasks across Regulatory Assistants based on timelines and workload
+ Track progress of assigned tasks and proactively address delays, quality issues, or resource constraints
+ Provide clear task-level guidance to enable efficient and consistent execution
+ スケジュールおよび業務量を踏まえ、薬事アシスタントの業務計画・優先順位付け・調整を実施
+ 割り当てた業務の進捗を管理し、遅延・品質課題・リソース制約に先手を打って対応
+ 効率的かつ一貫した実行を可能にするため、タスクレベルでの明確な指示を行う
**Cross-functional & System Support**
+ Support coordination with internal stakeholders to enable smooth regulatory operations
+ In response to requests from cross-functional teams, coordinate and support regulatory document formatting activities in collaboration with Regulatory Assistants, ensuring documents meet defined regulatory and submission-ready standards
+ Review formatted documents for compliance with established templates, formatting rules, and regulatory expectations prior to further use or submission
+ Operate regulatory systems (e.g., RIM and related tools), ensuring data accuracy and timely updates
+ Support preparation of meeting materials, minutes, and action tracking as required
+ 社内ステークホルダーとの調整を通じて、薬事オペレーションを円滑に支援
+ 他部門からの要請に応じ、薬事アシスタントと連携し、薬事文書のFormattingなどの支援を調整・実施し、定義された申請・規制要件に適合した体裁を担保
+ テンプレート、Formattingルール、薬事の観点での期待値に照らし、文書の体裁・整合性を確認
+ RIM等の社内管理システムを正確に運用し、データの適時更新と整合性を確保
+ 必要に応じて会議資料、議事録、アクション管理を支援
Knowledge and Skills
+ Solid understanding of regulatory operations and document management
+ Strong attention to detail and execution discipline
+ Ability to manage multiple tasks and timelines concurrently
+ Clear and professional communication skills in Japanese and English
+ Collaborative mindset with a strong sense of accountability
+ Regulatoryオペレーションおよび文書管理に関する基礎的理解
+ 高い正確性と実行力
+ 複数タスク・スケジュールを並行管理できる能力
+ 日本語・英語での明確かつ実務的なコミュニケーション能力
+ チーム志向と当事者意識
Education & Experience (Basic)
+ Bachelor’s degree
+ 3–5 years of experience in regulatory affairs, regulatory operations, or related pharmaceutical functions
+ 学士号
+ 医薬品業界におけるRegulatory、Regulatory Operations、または関連業務経験3–5年
Education & Experience (Preferred)
+ Experience supporting regulatory submissions or regulatory lifecycle management
+ Hands-on experience with regulatory systems (e.g., RIM)
+ 申請業務またはRegulatoryライフサイクル管理の実務経験
+ RIM等のRegulatoryシステム使用経験
