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
安全管理責任者 - Safety Control Manager Who we are: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with
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 CategoryProgram & Project Management Job Details About Salesforce Salesforce is
About Us Wellington Management offers comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique return and risk objectives of institutional clients in more than
At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and
At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and
About us Founded in 2017, Wayve is the leading developer of Embodied AI technology. Our advanced AI software and foundation models enable vehicles to perceive, understand, and navigate any complex environment, enhancing the usability and safety
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
Job Description SummaryJob 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 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
Who We Are Applied Materials is a global leader in materials engineering solutions used to produce virtually every new chip and advanced display in the world. We design, build and service cutting-edge equipment that helps our
The Data Center Infrastructure Delivery team at Oracle Cloud Infrastructure is a dynamic group of professionals dedicated to delivering state-of-the-art data center facilities at scale and at pace. This team comprises experienced project managers who work
Advanced IT and OT Engineer Koriyama Factory, Japan Join a brand-new IT/OT team where curiosity is contagious, the atmosphere is genuinely friendly, and your technical expertise will help deliver life-saving medicines to millions of patients. You’ll
Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of
The Peninsula Hotels, a division of The Hongkong and Shanghai Hotels Limited, operates twelve world-class luxury hotels across Asia, Europe, and the USA. Known for legendary hospitality, we offera guest experience that blends elegance with modernity.
COMPANY DESCRIPTION: A career here is life-enhancing. At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science
The People Business Partner is an individual contributor role responsible for executing people-related processes, programs, and local compliance activities in Japan with a high degree of reliability and judgment. Based in Tokyo, this role reports to
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
Job TitleSenior Operations Director, North Asia Job Description SummaryPOSITION OVERVIEW Cushman and Wakefield’s Data Centre Group Technical Services Asia Pacific specialises in the delivery and advisory of mission critical facilities, including data centres, digital infrastructure, utilities
Job Description Summary: The Microbiology Analyst, GDI – Tokyo Lab plays a critical role in supporting innovation, product quality, and food safety across The Coca Cola Company’s beverage portfolio. Based at the Tokyo Innovation Center, this