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
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
企業概要 Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。 求人内容 Manage contract and monitor the progress of all licensing relationships. This includes(i) maintaining good relationship with license partners and thus open the possibility of improvement/modification of terms, access to portfolio additions, etc, (ii)
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
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
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
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
【Job Purpose】 Sales & Business Development Manager is expected to drive and execute sales objectives by improving the existing programs, winning new programs to implement and developing new businesses, and attain the assigned financial goals such
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 Responsibilities The Supply Chain Business Manager defines metrics and monitors supplier performance against these expectations to ensure continuous supplier improvement. Regularly evaluates quality and sets performance benchmarks, and accesses the risks associated with the preferred
企業概要 IFS is a billion-dollar revenue company with 5000+ employees on all continents. We deliver award winning enterprise software solutions through the use of embedded digital innovation and a single cloud-based platform to help businesses be
【Job Purpose】 Business Development Director is responsible for developing new businesses in mobile Device Lifecycle Solutions (DLS) with assigned clients, turning efforts into closure of new deals, and achieving financial goals for assigned clients. 【Primary Job
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
Title: AFCAP V Japan BOS: KCS Maintenance - Electrical/HVAC Technician Belong, Connect, Grow, with KBR! Program Summary In support of the U.S. Air Force, KBR provides security, base operations, maintenance, and repair at Kyogamisaki and Shariki
Requisition ID: 200162 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. What your role will be. Customer Relations Representative As a member of the Dealer Finance Centre (DFC) Team
The role The Commercial Lead will be responsible for discovery, engagement, contracting, and account management for Hopper’s partnerships with critical 3rd party hotel providers and channel managers in markets we are newly entering. These partnerships will
The Customer Project Execution department is responsible for the overall execution of the Wind Farm from delivery of components, BOP Electrical & Civil Works, Installation & Commissioning works and testing, up to handing over of the
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 Operations Job Details About Salesforce We’re Salesforce, the Customer
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
POSITION SUMMARY Perform general office duties to support Sales & Marketing (e.g., filing, sending emails, typing, faxing, copying). Prepare sales-related documents throughout the sales process (e.g., proposals, contracts, or banquet event orders). Promote awareness of brand
