About Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For
職種 正社員 職務明細 Daxtra, the leading provider of AI-enriched software for the talent acquisition ecosystem, specializes in intelligent recruitment automation, semantic search and match, and multilingual resume and job parsing in 40+ languages. Built on AI and
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
Responsibility: バイオ品の新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築する バイオ品の新薬申請及び市販製品の変更管理におけるCMCのレギュラトリーリスクを時宜特定し、対応策を立案する 高品質のCMC承認申請資料を作成する。 規制当局からの照会事項に対してタイムリーな回答作成を行う。 バイオ品の新薬申請及び市販製品の変更管理におけるタイムリーな承認に寄与する 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。 Role: GSK Japanの開発品目におけるグローバル統一のCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略の構築、並びに市販製品の一部変更承認申請、軽微変更届出において、提言、方針決定、関連部署との交渉、必要に応じリソース配分等を自らも行い上司のサポートも行う。 当局対応において、承認時期への影響、GSKにおける承認後のグローバルビジネス及び国内での市販品の供給への影響等を鑑み、方針決定を行う、あるいはその提言を上司に行う。 他部署との協力業務におけるプロセス上の問題（役割分担等）の解決・調整をリードし、GSKとしてより良いプロセスを構築する、あるいはその提言を上司に行う。 複数の製品に共通のCMC関連課題／問題につき、海外関連部署と必要な協議を行う。 複数のproject team に対してCMC RA を代表したCMC薬事戦略の提案・提言を行う。 業界団体・学術団体等を通じCMCに関する規制調和を推進する。 Basic Qualification Skill 日本語又は英語により円滑なコミュニケーションのできる方 共に学びながら成長したい方 分析化学、有機化学または製剤・薬剤学（特に製造方法あるいはGMP）・生物学に関する知識がある方 Experience 企業での業務経験のある方（分析、製造、CMC薬事、開発等）（3年以上が望ましい） 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 Preferred Qualification Skill 英語環境での理論構築、読み書き、会話力等 Experience CMC薬事業務の経験 Why
What you will be responsible for: Senior Leadership in SSGA Japan As a Senior Managing Director of SSGA, you will be our most senior representative of SSGA in Japan taking on a key role representing SSGA
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for
About Applied Intuition Applied Intuition is a Tier 1 vehicle software supplier that accelerates the adoption of safe and intelligent machines worldwide. Founded in 2017, Applied Intuition delivers the definitive ADAS/AD toolchain and a world-class vehicle
This role required candidate to permanently relocate at Jubail, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
Company Description LinkedIn is the world’s largest professional network, built to create economic opportunity for every member of the global workforce. Our products help people make powerful connections, discover exciting opportunities, build necessary skills, and gain
Company Description At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for
SENIOR SALES MANAGER LUXURY, JAPAN Coty is one of the world’s largest beauty companies with an iconic portfolio of brands across fragrance, color cosmetics, skincare, and body care. COTY is the global leader in fragrance and
A successful Administrative Assistant possesses structure, attention to detail, quality focus, high energy and flexibility to a high-paced deadline driven organization. As a Securities Services Japan Admin Assistant - Fixed Term Contract in Corporate & Investment
Coty is one of the world’s largest beauty companies with an iconic portfolio of brands across fragrance, color cosmetics, skincare, and body care. COTY is the global leader in fragrance and number three in color cosmetics.
Job Purpose Background: Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. To achieve our ambitious
Organization Description Developed in partnership with jeweler and luxury products designer Bulgari, our select Bulgari Hotels & Resorts are located in major cosmopolitan cities and luxury resort destinations. Join our team and help deliver the excitement,
Company Description LinkedIn is the world’s largest professional network, built to create economic opportunity for every member of the global workforce. Our products help people make powerful connections, discover exciting opportunities, build necessary skills, and gain
