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?
Internal Audit As the third line of defense, Internal Audit’s mission is to independently assess the firm’s internal control structure, including the firm’s governance processes and controls, and risk management and capital and anti-financial crime frameworks,
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的 The Japan Medicine Development Lead (J-MDL) is accountable for a medicine development in Japan to ensure delivery differentiated medicines of value for patients, stakeholders and markets in Japan. The
Position Title Logistics Manager Location Tokyo, Japan Reports to Senior Director, Logistics, APAC Dotted Line Supply Chain Director - Japan Direct Reports 1 x Physical Distribution Operations Senior specialist Scope / Brands Japan Logistics operations ABOUT
Job Purpose: Responsible for driving commercial success in Japan LOC by leading GSK X-functional team Member of the Global/LOC cross-functional, shaping global strategy and co-creation Key Responsibilities: Understand global strategy and initiatives, as well as local
Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to
Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to
Required Vestas Offshore Service Readiness and Support Department, is part of the overall Offshore Service business in the APAC region, working closely with the Operational Service Team, Sales, Special Projects and Construction. Responsible for the service site setup,
We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace
JOB TITLE: FI Settlement Analyst / Associate Title: Associate Location: Tokyo, Japan Regular/Temporary: Employee Hire Impact: Enables support JGB settlement and Japan FICC business as a critical hire. Enables support delivery of OKR for FICC in
Job Description Job Summary: We are in search of a dedicated and experienced Workplace Specialist to optimize our office operations in Japan. The ideal candidate will be proficient in reception duties and have a strong background
About the Role: Grade Level (for internal use): 10 Senior Analyst (Corporate Governance & M&A) Background: S&P Global Governance Solutions and M&A team is seeking a highly skilled corporate governance expert for a consultative, advisory, and
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including
Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to
Location(s): Japan City/Cities: Tokyo Travel Required: 00% - 25% Relocation Provided: No Job Posting End Date: July 31, 2024 Shift: Job Description Summary: Focus, Scope, & Impact: The HR Director, People & Culture is responsible, in
Job title: Retail Operations Manager Business/Region: Pernod Ricard Travel Retail Asia - North Asia - Japan Line Manager: Sales Manager, TR Japan Location: Tokyo, Japan This position sits in our Global Travel Retail business (GTR). GTR
Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to
Job Description: Details of the Division and Team: The role is for an Auditor level position to join an established audit team in Japan and contribute to the diversification of the team’s coverage across Japan and
Company Description Wolt is a technology company that makes it incredibly easy to discover and get the best restaurants, grocery stores and other local shops delivered to your home or office. Since launching 7 years ago,
