Major Accountabilities

• Lead regulatory dossier publishing for major regulatory event (NDA, Expert Review, Drug Committee, Pharmaceutical Affairs Committee and other small submissions to Japanese HA) with support as appropriate
• Archive all regulatory submissions (Approval Letter, Minor Change Notification, BB, Answers to HA Questions, CTDs)
• Manage the company seal guideline
• Manage the 3rd party vendors for compilation of electronic/paper dossier (printing company etc.)
• Maintain information technologies in RA-J as Business Lead in IT project
• Support RA-J colleagues when they have a trouble in using RA IT system
• Provide RA IT system training for RA-J colleague as Business Administrator
• Enter / maintain RIMS data
• Improve RO work productivity by refining / developing SOPs, WPs, manuals, guidance
• Improve company-wide regulatory submission process
• Coach RO associates for routine jobs (including IT systems)
• Build relationship with other line functions, Global RO, Industrial Parties
• Advocate continuous improvement of quality
• Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
• 100% timely delivery of all training requirements including compliance

Minimum Requirements

• 医薬品または再生医療等製品における承認申請資料（CTD）や当局相談資料の作成過程に（できれば複数回）関与した経験がある方（承認申請資料構成等の規制要件を理解している方）
• 薬機法及びその他国内規制要件に準じた各種当局提出の資料構成や提出に必要なプロセスを理解して，業務を遂行できる方
• 承認申請プロジェクトチーム等のメンバーと連携し，各種当局提出のためのスケジュールを管理，取りまとめ，提出を推進できる方
• チームコラボレーション（主体的な関わりと効果的な連携）の意識を高くもって業務遂行できる方（Global membersや業務委託先とのコラボも含めて）
• 各種業務タスクのプロセス改善に対応経験（提案，合意形成，タスクリード，実装）があり，プロセス改善業務に対して意欲的に取り組む意識のある方（マニュアル通りのタスク遂行だけではなく，付加価値を主体的に追求することも責務であることを理解し，このコンセプトを実践できる方）
• Operational ExcellenceのMindをもち，Operationalな業務に対して創意工夫し，意欲的に取り組める方
• Microsoft Office等の基本的なPCアプリケーションだけでなく，Novartisが利用するGlobal systemやアプリケーションの使用経験があることが望ましい。また，新しいシステムに対しても意欲的に学ぶ意識がある方

Education

• Life Sciences or pharmaceutical in university
• Ph.D. or Master degree, and Pharmacist license is desirable

Experience / Professional requirements

• 5 years or more experience in pharmaceutical drug development
• Knowledge of regulatory requirements on format, structure and standard submissions and labelling. Understanding of basic regulatory operational processes and procedures
• Capability to proceed tasks in regulatory operations work with multiple regulatory submission projects even under uncertain situations
• Various experiences in IT systems utilized in regulatory operations (or equal experience in clinical development or potential)
• Design the structure and content of paper and electronic archives and databases
• Communication / negotiation skills (written and verbal)
• Various experience in process improvement proposal and its implementation through cross-functional collaboration
• Planning and tracking skills with ability to capture outlines in responsible projects
• Well organized, focused on results, capable of managing multiple projects, time management skills with respect to priorities and self-management
• Train and mentor junior associates in operational excellence
• Business use level of Japanese, and basic English (oral and written)
• English as business language

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