This is what you will do: The Senior Manager, Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA- CMC) in Japan will manage complex projects for CMC submission in Japan and responses to regulatory agency inquiries for Alexion’s commercial and investigational products.
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical
企業概要 About AbbVie 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
The Team Lead, Global Regulatory Affairs CMC - Japan is responsible for providing strategic leadership and operational oversight for the Global Regulatory Affairs CMC - Japan team. Reporting to the Head of Global Regulatory Affairs CMC you will partner
企業概要 About AbbVie 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
Position Summary: The Regulatory Affairs Manager will lead regulatory assessment and execution of post-approval changes for products in Japan, collaborating with internal teams, global colleagues, and external partners to ensure compliant and timely change controls. This role involves
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Job title: CMC Regulatory Manager Location: Hatsudai, Tokyo About the job Role & Responsibilities The incumbent regulatory professional is accountable for Japan strategic management of a portfolio of development projects and post-marketed products within Global regulatory CMC & Devices
Work Flexibility: Hybrid or Onsite Key Areas of Responsibility: Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
Principal Biostatistician / Programmer Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our
Job Description ・医薬品開発戦略に対して、臨床薬理/ファーマコメトリクスを活用した提案を行い、早期承認に貢献する ・他チームや臨床現場に対して、治験薬の臨床薬理学的情報を的確に提供するとともに、問題解決を行う ・プロトコールの試験デザイン・被験者数・解析方法並びに試料のサンプリングポイントなどを検討し、適切な提案を行う ・薬物動態（PK）解析を実施し、治験総括報告書の該当するセクションを作成する ・PK結果の速報を作成し配信する。 ・臨床現場に提供すべき治験薬の臨床薬理/薬物動態学的情報を精査し、非臨床ADMEを含む申請資料の臨床薬理関連部分に過不足無く盛り込む ・臨床現場に提供すべき治験薬の臨床薬理/薬物動態学的情報や用法・用量に関連する臨床薬理領域の電子データを特定し、戦略に応じて、適切に提出する ・PMDA相談の資料作成・当日の議論に臨床薬理担当者として加わり、承認に貢献する ・本社の担当者と継続的に連絡を取りながらこれらの業務を進める。 ・必要に応じてモデリング＆シミュレーション（M＆S）を実施する ・グループ内のM&Sスキル向上への提言及び下位部員に対するメンターとして教育・指導的役割を担う 応募条件 【必須（MUST）】 ・臨床薬理部門もしくは関連部門での3年～10年程度の実務経験 ・M＆S（population PK, PK－PDまたはExposure－Response解析）の知識・理解 ・非臨床ADMEの知識・理解 ・ノンコンパートメントPK解析の知識・理解 【歓迎（WANT）】 ・ノンコンパートメントPK解析の実務経験 ・M＆S（population PK, PK－PDまたはExposure－Response解析）の実務経験 ・各品目のプロジェクトチーム内で、他のメンバーと積極的に関わって議論/プレゼンできる方 ・海外の担当者とのメール、電話等でのコミュニケーションが可能で、関係を構築できる方 ・CDISC / non－CDISCの電子データ申請に関する基礎知識・経験があれば尚可 ・博士号（PhD）であれば尚可 Required Skills: Clinical Trial
About The Opportunity We are seeking experienced professionals in Finance and Financial Services to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will create and review high-quality,
Career CategoryClinical Job Description Job Purpose This position is responsible for providing statistical expertise and leadership for clinical development and regulatory filing activities in Japan as a member of Global Biostatistical Science Japan Biostatistics. The role will
About Kinaxis キナクシスでキャリアを前進させる新しい挑戦をしてみませんか？当社は技術のエキスパート企業です。しかし、より良い方法を追求する情熱の源泉は、ひとりひとりの従業員です。キナクシスでは皆さんのキャリアアップと専門的な能力開発に真剣に取り組んでおり、従業員を大切にしております。 1984年、私たちはカナダのオタワを拠点とする3人のエンジニアのチームとしてスタートしました。現在、当社は世界中に2,000人を超える従業員を擁し、100か国以上で40,000人を超えるユーザーをサポートするグローバル組織に成長しました。エンドツーエンドのサプライチェーン管理における世界的リーダーとして、当社はあらゆる業界のサプライチェーンの卓越性を実現します。当社は、お客様へのサポート方法の革新と大変革を継続しながら、東京および世界中でチームを拡大しています。 私たちは、セールス、プロフェッショナル サービス、グローバル カスタマーケアのプロフェッショナルで構成されるグローバルチームとして、10年以上にわたり日本での事業展開を続けており、SUBARU、日本光電、ユニリーバなど、日本および世界中のお客様をサポートしています。 Elevate your career journey by embracing a new challenge with Kinaxis. We are experts in tech, but it’s really our people who give us passion to always seek ways
Job Purpose At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive
About The Opportunity We are seeking experienced professionals in Mathematics to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will create and review high-quality, real-world mathematical scenarios
About The Opportunity We are seeking experienced professionals in Robotics to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will create and review high-quality, real-world natural sciences
About The Opportunity We are seeking experienced professionals in Natural Sciences to contribute to a cutting-edge AI benchmarking project in the target language. As a Subject Matter Expert, you will create and review high-quality, real-world natural
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Basic purpose of the job To plan and execute CDMA (Clinical Development & Medical Affairs) activities in Japan according to TA (Therapeutic Area) strategy. Confirmed target indication: Obesity disease, MASH (Metabolic dysfunction associated steatohepatitis). Accountabilities ・Gain