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Job Description SummaryシニアGPRM-Jとして、医薬品の開発段階から市販後に至るまでの薬事戦略を主導・支援し、日本における最適な承認取得および製品維持を実現する。日本およびグローバルの規制環境に精通した専門性を活かし、PMDA等の規制当局との信頼関係を構築するとともに、クロスファンクショナルおよびグローバルチームと連携し、ノバルティスの事業価値最大化に貢献する。また、業界活動や後進の育成を通じて、ノバルティス・ジャパンのリーディングカンパニーとしての地位確立を支える。 Job Description 業務内容： 医薬品の初期開発段階からプロジェクトチームに参画し、承認取得までの期間を通し、薬事戦略の立案、それに基づく開発プランの作成について中心的な役割を果たし薬事的リスクマネジメントを行う。 規制当局（PMDA, MHLW) 対応をリードし、プロジェクトチームの代表として関係当局との交渉に責任を持つ。例：開発プロジェクトの承認申請チームのリード Globalと協同し、世界同時開発・同時申請・同時承認の達成をドライブする。 各部門の担当者等と協働し、Product Life Cycle Planの最大化に貢献する。 業務のやりがい： 開発早期から承認取得、市販後まで薬の一生に幅広く関わることができる 規制や業界の流れを正しく読み取り、将来的な変化を見越した薬事戦略の立案/実行をリードできる 社内外の顧客や海外の開発関連部署など多くのメンバーと多岐にわたる仕事に携われる 個人としての作業に加えて、チームメンバーとの協働を通じて、申請・承認などの大きなマイルストーンも経験できる 社内外や規制当局も巻き込んで、AIやITテクノロジーを活用した先進的な医薬品開発を推進していくイノベーティブな活動にも参画できる 求められる主なスキル・経験： 1.開発薬事に関わる知識，経験 –医薬品開発，薬事規制に関する全般的な知識経験 –規制当局との折衝経験 2.コミュニケーション・ネゴシエーション・プレゼンテーション –社内の他部門との調整 –規制当局との折衝・交渉 –マネジメントへの報告 3.プロジェクトマネジメント –進捗管理，会議運営，記録作成等 4.リーダーシップ –規制当局対応、承認申請チームのリード 5.英語 –マネジメントへのレポートの作成・説明，global memberとの電話会議等の機会があるため，業務に支障が出ない程度の英語力が必要になります。
Company Description It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global
Company Description Nexthink is the leader in digital employee experience management software. The company provides IT leaders with unprecedented insight allowing them to see, diagnose and fix issues at scale impacting employees anywhere, with any application
Operation Project Manager / 運用プロジェクト責任者 This role has been designed as ‘Hybrid’ with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is
Job Description Purpose of the role To support business areas with day-to-day processing, reviewing, reporting, trading and issue resolution. Accountabilities Support various business areas with day-to-day initiatives including processing, reviewing, reporting, trading, and issue resolution. Collaboration with teams
About the Role Join our Digital & AI Transformation initiatives under Edwards Japan Quality team (Waku Waku DX Japan) working on real-world, Digital tools, and AI systems. This internship is designed not only as a learning
Summary: We are a US-based asset management firm that works in close collaboration with our global group companies — particularly those headquartered in the US — to provide asset management services across a diverse range of
If you’re looking for a career that will give you plenty of opportunities to develop, join HSBC and your future will be rich with potential. Whether you want a career that could take you to the
Job Description Summary: About the Program The Coca-Cola Company’s Ignite Internship Program is designed to provide students with hands-on experience in a dynamic, global organization. This program offers opportunities to work on impactful projects, develop professional
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
Job Description: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our
部署紹介/Business UnitLIGHTSPEED STUDIOS は、物語性の高いストーリー、没入感のあるゲームプレイ、最先端のテクノロジーを駆使し、ゲーム開発をアートとサイエンスの融合として追求し続けています。世界中のプレイヤー、そしてあらゆるデバイスに次世代のゲームエクスペリエンスを提供することを使命としています。 LIGHTSPEED STUDIOS is made up of passionate players who advance the art & science of game development through great stories, great gameplay, and advanced technology. We are focused on bringing next generation experiences to
Position Background Risk Analytics is seeking an Associate to support Counterparty Credit Risk Analytics IMM (Internal Models Method) projects and regulatory deliverables as well as other Risk Analytics coverage projects in Asia including Japan. The candidate
Our Mission At Palo Alto Networks®, we’re united by a shared mission—to protect our digital way of life. We thrive at the intersection of innovation and impact, solving real-world problems with cutting-edge technology and bold thinking.
Join our Team About us Ericsson is opening a state‑of‑the‑art R&D center in Yokohama focused on Radio and Software development. This new hub will support leading Japanese CSPs, partner with local vendors and deliver Japan‑driven products and
Join our Team About us Ericsson is opening a state‑of‑the‑art R&D center in Yokohama focused on Radio and Software development. This new hub will support leading Japanese CSPs, partner with local vendors and deliver Japan‑driven products and
Mgr Consulting I This role has been designed as ‘Hybrid’ with an expectation that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is the global
DISCOVER YOUR RESPONSIBILITIES The Manufacturing Methods Engineer is responsible for optimizing production performance across safety, quality, cost, and delivery (SQCD) dimensions through complex projects. They provide strong support to development teams by sharing their expertise in production
We are looking for a Marketing & Communication Manager who will be responsible for proposing and developing Zagato’s global marketing and communication strategy, strengthening its positioning in the luxury automotive segment and consolidating its iconic image