Responsibility: 変更提案に対する薬事影響評価（変更カテゴリ―、必要なデータ）の特定 市販製品（低分子医薬品及び/又はバイオ医薬品）の変更管理における薬事的なリスク低減策を含むCMC薬事戦略の立案・実行支援 薬事アクション（一変・軽変・相談・照会回答）に供する高品質な資料の適時作成 海外関連部署に対する本邦規制要件の提示・解説 （担当マネージャー）チーム成果物（提案・資料等）の品質保証（整合性、適切性） Role: 製造所の変更提案に対し適時薬事影響評価を行う。 市販製品の薬事アクション（一変・軽変・相談・照会回答）に対し、提言、方針策定の支援、海外を含む関連部署との交渉を行う。 薬事アクション（一変・軽変・相談・照会回答）に供する資料につき、海外薬事を含む国内外の品質部門と協働して資料作成を行う。 他部署との協業上の問題（役割分担等）の解決・調整を支援し、プロセス改善に寄与する、あるいはその提言を行う。 （担当マネージャー） チームメンバーの上記活動に対する能力開発を含めた指導・支援を行う。 関連部署との個別の課題／問題につき、必要な調整・解決のための協議を行う。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 Basic Qualification スキル Skill 分析化学、製剤・薬剤学・プロセス工学（特に製造方法あるいはGMP）等に関する知識 品質に関わる国内規制、各種ガイドライン及び日本薬局方などの知識 ロジカルシンキング（論理的に物事を整理し、本質を見極められる） 他者との緊密な協力関係を構築し、協業できること Word、Excel、PowerPoint、Outlook、 経験 Experience CMC関連業務（分析、製造、QA、CMC薬事など、関連業務5年以上が望ましい） CMC薬事経験必須、スタッフは関連業務経験の有無により以下を考慮することがある - 変更管理業務を含むCMC薬事への興味の高さ・習得意志の強さ - 業務に利用可能な傑出したスキル（例：英語がnative levelなど）またはコンピテンシー（自己認知・成熟性、変革行動、顧客志向性など）を1つ以上有する 学位/資格/語学力 Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上
Position Summary: The Regulatory Affairs Manager will lead regulatory assessment and execution of post-approval changes for products in Japan, collaborating with internal teams, global colleagues, and external partners to ensure compliant and timely change controls. This role involves evaluating
AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we’re the people who keep the cloud running. We support all AWS data centers and all of the
AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we’re the people who keep the cloud running. We support all AWS data centers and all of the
Over the last 20 years, Ares’ success has been driven by our people and our culture. Today, our team is guided by our core values – Collaborative, Responsible, Entrepreneurial, Self-Aware, Trustworthy – and our purpose to
About the OpportunityJob Type: Permanent Application Deadline: 31 August 2026 Title Japan Fund Accounting and Control Manager Department Fund Servicing and Oversight, Record Keeping Platform Location Tokyo Japan Reports To APAC Head of Fund Accounting and Control Level
About the OpportunityJob Type: Permanent Application Deadline: 31 August 2026 Job Description Title Financial Control, Associate Director, Japan Department Financial Control (CFO Group) Location Japan Tokyo Reports To Asia Pacific Financial Controller Dotted Line Head of Finance, Japan
Location:Tokyo, Tokyo, Japan Job ID: R0130881 Date Posted:2026-07-03 Company Name:HITACHI ENERGY JAPAN, LTD. Profession (Job Category):Engineering & Science Job Schedule: Full time Remote:No Job Description: Chief Engineer / Head of Architecture & Engineering — Network Control Japan
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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Job Description: Details of the Division and Team: Responsible for being the first point of contact for our external clients from inception to account closure. The purpose of the client services function is to enhance the
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