Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected,
Job Description Job Responsibilities: Develop and execute strategies that align with the global business units’ strategy. Focus business areas products include ImmunoDiagnostics and Molecular Diagnostics. and other areas may be added as appropriate. Identify and evaluate
Job Description Job Summary: To ensure that clinical supplies are stored and distributed in accordance with Fisher Clinical Services (FCS) approved procedures and policies, cGMP, cGDP, and regulatory requirements. Maintain the FCS Japan Quality System in compliance
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
Job Description Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen. Manage and maintain regulatory operational activities in drug development, NDA
Company Description We are PrimeVigilance (part of Ergomed PLC), 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
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
Are you experienced in CMC regulatory affairs or in generating high-quality documentation related to drug manufacturing and marketing approval/maintenance? Do you have a strong understanding of CMC requirements in Japan? We are seeking a CMC Expert to join
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
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
This is a contractor role untill End of Mar 2025 医薬品,医療機器等の品質,有効性及び安全性の確保等に関する法律(以下,薬機法) 及び関連法規に基 づく,医薬品,医薬部外品の薬事承認申請,⾏政対応,外国製造所との対応等の業務を,業務報告者の監督の下に行う 。 • 医薬品又は医薬部外品の薬事承認申請,届出 • 医薬品又は医薬部外品の変更管理業務(適切なRegulatory Assessmentの実施) • 外部講習会及び関連学会への参加等による薬事•業界知識の向上及び部内への伝達•理系大卒以上 • 5 年以上の CMC 薬事の経験。若しくは CMC 研究または生産部門で 5 年以上の業務経験と, CMC 申請資料作成の経験があり,薬事業務に興味と意欲がある。 •海外カウンターパート及び国内関係部門と連携して業務を遂行する調整能力がある。 •複数の製品の次々に発生する変更事項について,複数の国の変更申請を確実に履行するための,整理•計画•実行能力がある。 •業務上必要な英語の読み書きと会話ができ,さらに上達意欲がある。 ( 目安:
Take lead in diverse range of RA projects to support clients in obtaining regulatory approval. Provide expertise in RA strategy/development. Client Details * One of the largest global CROs in the industry * Partnering with small to
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Disability Hiring-Business Operations Specialist - Tokyo, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000422753 Date Posted: 2024-04-17 Location: JPN - Tokyo, Japan Job Description Qualifications: (Japanese Follows) Boeing Global Enterprise Services (BGES) has an exciting
