職務の目的 規制当局及び社内関連部署と良好な関係を築き、規制当局との窓口業務を適切に遂行し、承認前GMP適合性調査、定期的なGMP適合性調査及び外国製造業者認定の新規取得／管理を確実に行う。 主な業務内容 下記業務における規制当局窓口業務（申請・照会事項対応） 新薬申請時の承認前GMP適合性調査 一部変更承認申請時の承認前GMP適合性調査 定期GMP適合性調査 外国製造業者認定 新規申請・更新・変更 必要な条件 海外と口頭でコミュニケーションができる最低限の英語力（リスニング、スピーキング）（TOEIC600点～） 社内関連部署及び当局と交渉するためのコミュニケーション能力 スケジュール管理能力 製薬業における業務経験 リーダーシップ 望ましい条件 高度な英語力（TOEIC700点～） 医薬品製造・品質保証に関する知識・経験 医薬品製造販売承認申請書に関する知識・経験 GMPに関する知識・経験 ピープルマネジメントの経験 Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Meta is seeking a Head of Public Policy, Japan to help us manage policy issues in Japan and engage key stakeholders to demonstrate the value of our family of apps and our innovation products such as
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock
THE ROLE: The Senior Manager - Business Service Architecture will be responsible for designing, leading and overseeing the architecture of robust and scalable solutions for delivering real-time financial data. This role requires deeps technical expertise, business
Basic purpose of the job The manager of RRL JP provides strong leadership to develop and implement regulatory strategy for the assigned products/projects as RRL JP, and exercises activities which include: An integral member of the Regulatory Excellence
Company Description Working in partnership with our clients, we deliver major projects and programmes with skill and precision, by focusing on outcomes and driving high performance. Delivering innovative solutions and exceptional outcomes across our sectors, we
Key Responsibilities: • Support the launch planning and commercialization of Belamaf for Multiple Myeloma in Japan. • Develop commercial materials to support the key message strategy. • Work as part of a cross-functional team to ensure
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Company Description Publicis Groupe is not just a company you work for; it’s a platform for you to take your talent to the world. If you want to help change the world, ideas alone are not
企業概要 アコーは世界で約5000軒以上のホテルを展開し、ホスピタリティー産業においてヨーロッパではリーダー的存在です。現在日本国内では、Mギャラリーコレクション、プルマン、スイスホテル、グランドメルキュール、ノボテル、グランドメルキュール、メルキュール、イビス、イビススタイルズ、イビスバジェットの各ブランド計45軒を展開しております。 Accor operates over 5,000 hotels worldwide and is a leader in the hospitality industry in Europe. Currently, in Japan, Accor operates a total of 45 hotels under the following brands: MGallery Collection, Pullman, Swissotel,
Job Description 募集メッセージ 非臨床の専門性を発揮して、医薬品の開発、承認申請及びライフサイクルマネジメントに貢献いただける、意欲ある方を求めています。 職務内容 非臨床（薬理、毒性）担当者としてプロジェクトチームに参画し、医薬品の国内開発、承認申請及びライフサイクルマネジメントにおいて、以下に示す非臨床試験に関する業務を遂行する 米国本社より入手した非臨床試験情報を精査し、国内開発における非臨床関連の課題を抽出、解決する 臨床試験、承認申請、上市に必要な薬事資料の非臨床パートを作成する（治験薬概要書、機構相談資料、承認申請資料（CTD M2.4及び2.6）など） 規制当局や治験実施施設からの非臨床関連の照会事項に対して、科学的妥当性の高い回答を米国本社と共同で作成する 医療機関などからの上市製品についての非臨床関連の照会に対して回答を米国本社と共同で作成する 応募資格 Required Qualifications： 研究施設での薬理又は毒性試験の実施経験 医学、薬学の基本的知識 生命科学系修士以上 英語文献の読解能力 協調性があり、自発的動機づけができ、根気よく課題や問題解決に取り組める姿勢 Desired Qualifications： 医薬品開発に関する薬事規制（ICHガイドラインなど）の知識 医薬品開発における非臨床薬事資料の作成経験 海外担当者とコミュニケーションができるレベルの英会話、英作文能力 Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives
This role involves developing and executing marketing strategies to drive brand growth in the Japanese market. The position requires collaboration with multiple departments to ensure successful brand positioning and market penetration. Client Details Our client is
About Sayari: Sayari is the counterparty and supply chain risk intelligence provider trusted by government agencies, multinational corporations, and financial institutions. Its intuitive network analysis platform surfaces hidden risk through integrated corporate ownership, supply chain, trade transaction
ERM is looking to recruit an experienced regulatory affairs professional with experience with Crop Protection regulations to join our Sustainable Products and Supply Chain (SP&SC) team. This role would be based in the Japan. The role We
Role profile: The Partners team identifies, engages and manages a growing ecosystem of partners that delivers enhanced workflow solutions to our customers and drives revenue growth for LSEG. We have an excellent opportunity for a business
As one of the world’s leading asset managers, Invesco is dedicated to helping investors worldwide achieve their financial objectives. By delivering the combined power of our distinctive investment management capabilities, we provide a wide range of
Who we are looking for Develops and implements the compliance program for State Street Trust and Banking Co., Ltd. and State Street Bank and Trust Company Tokyo Branch. Enhance risk management for the business in SSGM
In this administrative role, the Office Manager will be responsible for overseeing and executing on activities essential for the smooth operation of KLD’s Tokyo office. The Office Manager will be working independently to anticipate and proactively
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 CategoryCustomer Success Job Details About Salesforce We’re Salesforce, the Customer
