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
Department:Regulatory CMC Japan Report to:Head,Non-clinical & CMC Dev 1. Act as a key person to coordinate CMC and/or regulatory science issues between global and Japan so that appropriate solutions are provided 2. Be responsible for preparation of Appliation
Key Accountabilities: Develop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders. Regulatory Affairs Manager will focus on some of the following activities in Regulatory Affairs Group 1
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes
Job title: Senior Manager, Regulatory Affairs Location: Hatsudai Tokyo About the Job Position Summary The Senior Manager, Regulatory Affairs serves as the Japan regulatory lead for assigned development projects. This role is responsible for formulating and executing Japan regulatory strategies in alignment
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
メルクと一緒に、あなたの力を発揮しよう！ 冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう！科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか？ 患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。 YOUR ROLE This role provides a unique opportunity to make a significant impact in the pharmaceutical industry while working in a dynamic and supportive environment. As the CMC Regulatory Senior Manager, you will serve as
This is what you will do: The Senior Manager, Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA- CMC) in Japan will manage complex projects for CMC submission in Japan and responses to regulatory agency inquiries for Alexion’s commercial and investigational products.
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical
Job Description: Business Overview Rakuten is Japans largest marketplace and Internet ecosystem, offering a wide range of more than 70 services, including e-commerce, travel, banking, fintech, food delivery, golf, insurance, instant messaging, and mobile networking. Rakuten
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job CategoryReal Estate & Facility Management Job Details About Salesforce Salesforce
Adventus is an Information and Communications Technology (ICT) Solutions and Services Provider with a wide footprint across the globe. We help organizations bring about positive transformation to their businesses by leveraging intelligent applications of innovative solutions
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the
Meta is seeking an experienced Public Policy Manager to contribute to Metas policy engagement in Japan. In this role, you will work under the leadership of the Head of Public Policy, Japan, proactively engaging with Japanese government
Purpose of the Role Manage activities of planning and scheduling group to achieve targeted service and Inventory levels while controlling operational costs. Meet established objectives. Support employees in Planning and Scheduling while acting as a technical
Job Description 1. Quality Management of third-party manufacturers and suppliers 2. Quality Operations of EM CHC JAPAN Entity 3. Quality Training 4. Quality Technical Support The EM CHC JAPAN Senior Quality Manager (EM CHC JAPAN - SQM)
Primary Purpose / Regulatory Responsibilities: The primary purpose of a Project Manager (PM) is to ensure and elevate the level of country operations to realize patient value by transforming company’s strategy into project delivery in Japan. A PM’s