Your work days are brighter here. At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software
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 GSK?
Cohesity is a leader in AI-powered data security and management. Aided by an extensive ecosystem of partners, Cohesity makes it easy to secure, protect, manage, and get value from data — across the data center, edge,
Acquia empowers the world’s most ambitious brands to create digital customer experiences that matter. With open source Drupal at its core, the Acquia Digital Experience Platform (DXP) enables marketers, developers, and IT operations teams at thousands of
Eligibility Criteria: 1. For any experience of 1 year (non-aviation in service industry or aviation industry) +12/ Diploma is mandatory 2. Graduation is mandatory for freshers and degree certificate is essential. 3. Candidates should not have
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 Category Sales Job Details About Salesforce We’re Salesforce, the Customer
About Four Seasons: Four Seasons is powered by our people. We are a collective of individuals who crave to become better, to push ourselves to new heights and to treat each other as we wish to
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
LocationOur Account Executive will be an integral part of our Sales team in Japan. This role is based remotely in Japan. Who We Are DoiT is a global multicloud innovator that helps simplify the most important cloud challenges.
Were Celonis, the global leader in Process Mining technology and one of the worlds fastest-growing SaaS firms. We believe there is a massive opportunity to unlock productivity by placing data and intelligence at the core of
About Glean We’re on a mission to make knowledge work faster and more humane. We believe that AI will fundamentally transform how people work. In the future, everyone will work in tandem with expert AI assistants
About Glean We’re on a mission to make knowledge work faster and more humane. We believe that AI will fundamentally transform how people work. In the future, everyone will work in tandem with expert AI assistants
Our Equity Research team is fast-paced, demanding and intellectually stimulating! As a Vice President in Equity Research team, you’ll primary take responsibilities for industry analysis and company-specific coverage within the sector, with the opportunity to take on lead
Company Description We are Wix’s Enterprise team. We’re a new team focused on becoming the go-to solution for large companies looking to maximize their potential online. Through a combination of forward-thinking design language and a smart, savvy tone
Tulip, the Frontline Operations Platform, is empowering the world’s leading manufacturers to improve the productivity of their teams, the quality of their output, and the efficiency of their operations. With Tulip’s no-code platform, manufacturers can empower those
At World Kinect, our employees are the key to our global success. We are industry leaders due to the innumerable talents of our approximately 5000 strong professional team. Our people thrive in an entrepreneurial and culturally-diverse environment,
Figma is growing our team of passionate people on a mission to make design accessible to all. Born on the Web, Figma helps entire product teams brainstorm, design and build better products — from start to finish. Whether
About Us Always open. Our code, our culture, our opportunities. Leading open innovation without limits. We are SUSE. SUSE is a global leader in innovative, reliable and secure enterprise open source solutions, including SUSE Linux Enterprise
Asana has emerged as the leader in the work management category. Launched commercially in 2012, our success is linked to our culture, employees, and commitment to our mission: to help humanity thrive by enabling all teams to
About the role - Do you enjoy speaking English? - Are you detail oriented? - Do you want to join an international market leader with a mission to help people? We are looking for a Payments
