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?
Work Flexibility: Hybrid or Onsite Position summary: Work as part of the Network Services Integration team to deliver network infrastructure projects in line with identified requirements. Work with key stakeholders to ensure that all deliverables are
Job Description At Thermo Fisher Scientific, each one of our 125,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and
Fender Musical Instruments Corporation is a world famous brand with offices across the globe. An American icon, Fender was born in Southern California and has built a worldwide influence extending beyond the studio and the stage.
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,
JOB SUMMARY Shapes and executes an overall marketing strategy. Communicates this strategy to the marketing team and other business units. Coordinates with sales management in order to ensure alignment of marketing and sales strategies. Evaluates past
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
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
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
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
Business Overview MACDERMID ENTHONE INDUSTRIAL SOLUTIONS MacDermid Enthone Industrial Solutions is a global supplier of industrial metal and plastic finishing chemistries. We primarily design and manufacture chemical systems that protect and decorate surfaces. Our high-performance functional
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
Requisition #: 14356 Our Mission: Powering Innovation That Drives Human Advancement When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more
JOB SUMMARY Functions as the property’s strategic financial business leader. The position champions, develops and implements property-wide strategies that deliver products and services to meet or exceed the needs and expectations of the brand’s target customer
Account Manager This role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE partner/customer office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way
JOB SUMMARY Functions as the property’s strategic financial business leader. The position champions, develops and implements property-wide strategies that deliver products and services to meet or exceed the needs and expectations of the brand’s target customer
JOB SUMMARY Must have Japanese citizenship or Eligible work in Japan permit holder Functions as the property’s strategic financial business leader. The position champions, develops and implements property-wide strategies that deliver products and services to meet
企業概要 シーカは、建築分野や自動車産業における接着、シーリング、制振、補強、保護のための革新的なシステムや製品の開発・生産で世界をリードする特殊化学品会社として、世界的に認知されています。世界101カ国に子会社を持ち、300以上の工場を持つシーカは、全世界で33,000人以上の従業員を擁し、2022年度の売上高は105億スイスフランでした。日本では、シーカは長い歴史を持ち、1200人以上の専門家からなる献身的なチームを擁しています。 求人内容 Objectives of position Reporting to the General Manager, this position will be responsible for the Controlling Function of the company, including, but not limited to, organizing and managing a local accounting and finance
Job Responsibilities This position is part of the Global Supplier Management (GSCM) organization. In this position, you, the correct applicant will play a vital role with Technology Commodity suppliers. You will help establish/ sustain world class
JOB SUMMARY Supports the day-to-day execution of general ledger impacted processes, including support to clients as they work with and understand these processes. Performs accounting functions specifically in the areas of account balancing, ledger reconciliation, reporting
