Regulatory Support Excellence – Senior Associate

Career Category

Job 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)

• Bachelors degree
• 35 years of experience in regulatory affairs regulatory operations or related pharmaceutical functions
• 学士号
• 医薬品業界におけるRegulatoryRegulatory Operationsまたは関連業務経験35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