Job Purpose and Impact The Industrial Chemical Regulatory Specialist II will ensure compliance with government chemical regulations or standards in the areas of product compliance, hazard communication, customer documentation and other regulatory functions. In this role, you will
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
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:
JOB DESCRIPTION Job Title: Associate Director, Regulatory Affairs Japan Department / Cost Center: Regulatory – 210 Reports to (Job Title): Head of APAC Regulatory Affairs Job Code: Location: Tokyo Date Prepared: April 2024 Full-Time Part-Time Regular Temporary Exempt Non-Exempt SUMMARY DESCRIPTION
職位記述書 職務名 薬事規制スタッフ 勤務地 東京本社 レポート先 Quality, Safety & Regulatory Manager 担当ディビジョン Consumer Beauty & Luxury /Rimmel, Gucci, Burberry, CK, Tiffany,etc. 雇用形態 正社員 (full time) 業務内容 化粧品製造販売業者コティジャパンの薬事業務の遂行 主要業務 (70%) コティジャパン薬事規制業務 マーケティングおよび R&D と協力し、製品の成分、製品訴求、および製品表示が日本の規制に適合している事の確認 化粧品の申請書類作成・申請業務 化粧品の届出業務 (30%) 安全管理責任者(安責)業務
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.
Johnson & Johnson is the worlds most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in pharmaceutical, and medical devices and
SUMMARY Responsible and accountable for Medical Affairs strategy of Urological cancer products C ollaborates with internal and external stakeholders including key opinion leaders to develop and implement the overall M edical Affairs strategy for product lifecycle align ed
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
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,
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
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
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,
Business Operations Specialist - Tokyo, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000422120 Date Posted: 2024-04-30 Location: JPN - Tokyo, Japan Job Description Qualifications: (Japanese Follows) Boeing Global Enterprise Services (BGES) has an exciting opportunity
* At the front line of communication with stakeholders at hospital sites / clinics, youll manage clinical aspects of full-service global trial projects. Your responsibilities will include ensuring timelines, targets, and standards are met for clinical
Leading the local trial team to deliver results compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements. Actively contributing to process improvement and site management, you will train 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
Lime is the worlds largest shared electric vehicle company. We’re on a mission to build a future where transportation is shared, affordable and carbon-free. Our electric bikes and scooters have powered 400+ million rides in 250+