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?
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
KLDiscovery, a leading global provider of electronic discovery, information governance and data recovery services, is currently seeking an Associate Business Development Manager for an exciting new opportunity, based in the Toyko, Japan. In this role you
Senior Inside Service Sales Rep– Service Sales, APAC Senior Inside Service Sales Rep is an experienced professional, integral part of the Juniper APAC field sales team responsible to obtain and grow customer accounts for assigned Named
Reporting to the MarCom Director, will play a key role in shaping the brand’s media communications to meet the luxury brand consumer’s behaviors and interests. Manage press sample, conduct appointment product lending daily basis to evaluate
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
Are you looking for your next “great mission” professionally? Do you feel like you have more to give, want to learn new skills and be part of a team with a rewarding mission supporting our Active-Duty
Make a difference in the lives of our military Service Members and their families with your expertise in counseling and behavioral health – without the fuss of insurance or paperwork. Military and Family Life Counselors (MFLCs)
Make a difference in the lives of our military Service Members and their families with your expertise in counseling and behavioral health – without the fuss of insurance or paperwork. Military and Family Life Counselors (MFLCs)
Presales Consultant for Labels & Packaging Segment (Industrial Print) デジタル印刷機プリセールス Description - Job Summary • This role is responsible for establishing customer relationships, supporting sales strategies, and assessing client needs and concerns to tailor solutions. The
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
JOB SUMMARY Manages the daily functions of the department to ensure protection of property assets, employees, guests and property. Maintains logs, certifications and documents required by law and Standard Operating Procedures. Trains staff in established emergency
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 team,
Company Description The Sales Controller is responsible for the financial partnership with Red Bull Japan’s Sales teams, through the preparation, presentation and influence of valuable analytical insights which encourage smarter, more informed decision making. The purpose
Associate Manager, Customer Solution Center - Technical Description - Job Summary • This role is responsible for managing teams engaged in remote service, customer access, pre-sales, and post-sales activities related to business systems and application problems.
City/State Elizabeth City, NC Overview Work Shift First (Days) (United States of America) As a Patient Care Specialist with Sentara Healthcare, you will provide non-clinical support within a physicians office and ensure an excellent patient experience
Inside Service Sales Rep– Service Sales, APAC Inside Service Sales Rep is an experienced professional, integral part of the Juniper APAC field sales team responsible to obtain and grow customer accounts for assigned Named accounts and
Leidos is hiring licensed behavioral health professionals to join our Adult Military and Family Life Counseling (MFLC) team to support Camp Fuji, Japan Immediate need Join the mission to support U.S. military service members and their
Company Description The Sales Controller is responsible for the financial partnership with Red Bull Japan’s Sales teams, through the preparation, presentation and influence of valuable analytical insights which encourage smarter, more informed decision making. The purpose
JOB SUMMARY The Marketing and Communications Manager is part of an important team that creates and executes property-level communications to our customers. Under the leadership of the Director of Marketing and Communication, this role promotes on-brand
