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
Are you looking to become a true HR Business professional at a global organization? Do you enjoy partnering as a strategic executor supporting multiple units? About the Role The HRBP supports business growth and strategy implementation
JOB SUMMARY Functions as the leader of the property’s sales department for properties with bookings over 300 peak rooms and significant local catering revenue. Manages the propertys reactive and proactive sales efforts. Provides day to day
Country Director – Japan Are you ready to unleash your potential in a global business that is committed to moving money for the better? How about helping drive successful strategies that will transform the customer and
Company Description Wafer prices for advanced processes are high, and the cost impact of manufacturing yield is very large. To improve yield, it is important to investigate the root causes of failures and improve manufacturing processes
JOB SUMMARY 日本語が話せることを条件といたします。 Areas of responsibility include Restaurants/Bars and Room Service, if applicable. Supervises daily restaurant operations and assists with menu planning, maintains sanitation standards and assists servers and hosts on the floor during peak meal
JOB SUMMARY Accountable for the quality, consistency and production of the restaurant kitchen. Exhibits culinary talents by personally performing tasks while leading the staff and managing all food related functions. Coordinates menus, purchasing, staffing and food
Minimum qualifications: Bachelors degree or equivalent practical experience. 15 years of experience in HR business partnership roles, at regional or country level. Experience with employment laws, labor relations, and compliance in Japan. Ability to communicate in
Responsibility: Co-develop global medical strategy to cater local unmet medical needs Support local EE network development and transfer of relationship ownership to Vaccine and Infectious Disease team Deep capabilities of MSLs to have a meaningful exchange
About Appier Appier is an AI SaaS company on a mission to make AI easy, by making software intelligent. Founded in 2012, Appier has 17 offices across APAC, U.S. and Europe and is listed on the
JOB SUMMARY Assists the Front Office Manager in administering front office functions and supervising staff on a daily basis. Front office areas include Bell/Door Staff, Switchboard and Guest Services/Front Desk. Position directs and works with managers
JOB SUMMARY Accountable for overall success of the daily kitchen operations. Exhibits culinary talents by personally performing tasks while leading the staff and managing all food related functions. Works to continually improve guest and employee satisfaction
JOB SUMMARY Manages all outlet operations and staff on a daily basis. Areas of responsibility include Restaurants/Bars and Room Service, banquets. As a department head, directs and works with the food and beverage/culinary management team and
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 Assists in successfully planning, developing, implementing, and evaluating of the quality of property’s rooms. The position ensures Rooms Operations meet the brand’s standards and targets customer needs. Strives to continually improve guest and employee
As a trusted global transformation partner, Welocalize accelerates the global business journey by enabling brands and companies to reach, engage, and grow international audiences. Welocalize delivers multilingual content transformation services in translation, localization, and adaptation for
About Zscaler Zscaler (NASDAQ: ZS) accelerates digital transformation so that customers can be more agile, efficient, resilient, and secure. The Zscaler Zero Trust Exchange is the company’s cloud-native platform that protects thousands of customers from cyberattacks
Job Description: Essential Job Functions: • Provide essential support to the Talent Acquisition team by actively participating in candidate sourcing and screening. • Collaborate with the team on various recruitment projects and initiatives, bringing fresh insights
Job Description: Essential Job Functions Provides service delivery and support in recruitment and employment, new business, employee reassignment, personnel records, employee and/or labor relations, job evaluation, compensation management, benefits administration, organization development, training, AA/EEO, and special
JOB SUMMARY 日本語スキル必須 / Japanese language skill is a must. 担当エリアは、レストラン／バーおよびルームサービスが含まれる（該当する場合）。 日々のレストラン運営を監督し、メニュープランニングのアシスト、衛生基準の維持、食事のピーク時のフロアでのサーバーやホストをアシストする。 ゲストと従業員の満足度を継続的に向上させ、責任分野の財務パフォーマンスを最大化するよう努める。 目標達成のために必要なトレーニングを決定し計画を実行する。 Areas of responsibility include Restaurants/Bars and Room Service, if applicable. Supervises daily restaurant operations and assists with menu planning, maintains sanitation standards
