Basic purpose of the job To contribute to global clinical drug development by executing CDMA activities in Japan according to TA strategy between start of preclinical development and late stages of commercialisation Accountabilities Contribution to Clinical
Company Description We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North
Job Description About This Role This role is serving as IT focal point for Japan R&D, acting as IT Business Analyst, affiliate level of IT project manager and supporting Japan R&D members for any kinds of
職種 正社員 職務明細 Tokyo-based Langley Esquire is a public affairs consulting firm specializing in government relations, strategic communications, and public policy. We overcome challenges at the nexus of government, industry, and society. With over 30 years of
職種 インターンシップ 職務明細 Tokyo-based Langley Esquire is the premier public affairs consultancy dedicated to solving issues in Japan’s unique regulatory environment. We overcome unprecedented challenges at the nexus of government, business, and society. With over 30 years of
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
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
Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe,
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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
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
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
職種 正社員 職務明細 Inspiring Change, Shaping the Future. At Gemini Group, we believe in the power of civic engagement to transform society. Our mission is to drive meaningful, positive change in Japan by influencing public policy,
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied
Career CategoryRegulatory Job Description Group Purpose Japan Regulatory Affairs provides leadership, expertise, and execution for the regulatory strategy to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan in alignment with local business priorities and
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
企業概要 AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across
Principal Responsibilities ・Accountable as Regulatory Lead to develop and implement regulatory strategies for assigned product(s)/project(s) in Japan and accountable to provide regulatory advice to cross-functional strategies and associated deliverables according to business objectives. ・Lead the planning and conduct of
