Company Description PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical
Job Description The Role The Japan Quality Management and Regulatory Affairs (QM & RA) team is responsible for ensuring the quality and regulatory compliance of ADM products distributed in the Japan and Korea markets. The team works closely
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
Institutional Securities Documentation Documentation Negotiator – Vice President Institutional Securities Documentation is a global team consisting of approximately 160 people based in several locations (including New York, London, Hong Kong, Budapest, Mumbai and Tokyo). The current opening is for
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。
The Team Lead, Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team. Reporting to the Head of Global Regulatory Affairs CMC you will partner
About Anthropic Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing
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企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and
Led by Rodolphe Saadé, the CMA CGM Group, a global leader in shipping and logistics, serves more than 420 ports around the world on five continents. With its subsidiary CEVA Logistics, a world leader in logistics,
Led by Rodolphe Saadé, the CMA CGM Group, a global leader in shipping and logistics, serves more than 420 ports around the world on five continents. With its subsidiary CEVA Logistics, a world leader in logistics,
JOB SUMMARY Provides a high level of property maintenance knowledge. Position has overall responsibility for maintaining the building, grounds and physical plant with particular attention towards safety, security and asset protection. Accountable for managing the budget,
Were looking for a Manager, Strategic Partnerships & Communications, Japan to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you ready to be
We exist to create positive change for people and the planet. Join us and make a difference too! Job Title: HR Generalist Location: Yokohama About the role We are looking for an experienced and people-focused HR
We exist to create positive change for people and the planet. Join us and make a difference too! Job Title: Employee Relations Specialist Location: Yokohama, Japan About the role We are looking for an Employee Relations
Company Description In a changing and evolving world, challenges are ever more unique and complex. Nagarro helps to transform, adapt, and build new ways into the future through a forward-thinking, agile, and caring mindset. Today, we
Executive Summary of the Role: The Lead Solution Architect for the Insurance Claims area is a critical role responsible for overseeing the end-to-end design and execution of the Claims Modernization Program. This role ensures that the
Company Description Wise is a global technology company, building the best way to move and manage the world’s money. Min fees. Max ease. Full speed. Whether people and businesses are sending money to another country, spending
Basic purpose of the job To contribute to execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy between start of preclinical development and late stages of commercialization. Accountabilities ・Strengthen