Works directly with GRA Leadership, GRA personnel, as well as PMO and Finance in leading the project review process, raising issues for resolution, ensuring action items are completed, and communicating the health of both project and
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:
Company Description Block is one company built from many blocks, all united by the same purpose of economic empowerment. The blocks that form our foundational teams — People, Finance, Counsel, Hardware, Information Security, Platform Infrastructure Engineering,
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be
You are a team contributor who enjoys working collaboratively Opportunity to innovate and drive pioneering business initiatives Together we can drive sustainable business growth for our clients Do work that matters: We’re undergoing a rapid transformation,
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
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
Office : Shiodome Office Division： Regulatory Strategy Department Job level： Staff Report to： Group Manager Contract type： Full time Roles & Responsibilities 攻めと守りの戦略ができる薬事マーケティング担当者。具体的には以下の業務を含む（以下に限定されない）。 ・国内外薬事面からの情報開発支援 ・国内外広告訴求・製品表示の法規適合確認 ・国内外の化粧品規制の情報収集 ・薬事セミナーやデータベース構築によるメンバーへのスキル継承 Requirements ・薬事業務（広告訴求確認、法定表示確認、医薬部外品申請及び化粧品届）に関する知識を有しており、実務経験５年以上を有していること。 ・グローバル各国の化粧品に関する法規制や風評、トレンドを把握していて、過去や現在ではなく、今後求められるベネフィットが何かをイメージできる人材。 ・科学的な根拠やデータの理解、さらに当社のブランドの特性などさまざまな視点で判断できるスキルを求める。 ・英語を仕様して業務が遂行できる人材。...
Minimum qualifications: Bachelors degree or equivalent practical experience. 4 years of experience with project or program management. Experience working with external auditors or regulators. Ability to communicate in Japanese and English fluently, to work on compliance
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
About ERM: Sustainabilityis our business. As the largest global pure play sustainability consultancy, ERM partners with the world’s leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today
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.
At Airwallex (airwallex.com), we’re building the future of global finance on one platform. Founded in 2015 in Melbourne, Airwallex is the leading financial technology platform for modern businesses to grow beyond borders. With one of the
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
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.
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
Job Description: Employer: DWS Group Title: Senior Coverage Specialist – Retail Investment Sales Location: Tokyo Job Code: #LI-ZL1 #LI-03 About DWS: Today, markets face a whole new set of pressures – but also a whole lot
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+
