Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON)
Job TitleRegulatory Affairs Manager Job Description Job Title Regulatory Affairs Manager ポジション概要 フィリップスの医療機器事業において、Hospital Patient Monitoring（HPM） および Sleep & Respiratory Care（SRC） 領域の新製品導入および既存製品の許認可維持を担うポジションです。 また、AIを活用したプロセス改善・業務変革の推進にも携わり、日本国内のみならずグローバルチームと連携しながら、Patient Safety & Quality（PSQ）全体に影響を与える変革活動をリードしていただきます。 薬事の専門性に加え、組織横断での協働やリーダーシップを発揮し、事業成長とコンプライアンスの両立に貢献いただくことを期待しています。 主な業務内容 薬事戦略・申請業務 製品ライフサイクル全体を通じたコンプライアンス確保に向け、国内薬事戦略を策定し、関連ステークホルダーとの戦略的な議論をリードする 薬事戦略、開発計画および製品に関する規制リスクを主体的に特定し、適切な代替案を提案する 国内規制要件を解釈し、海外設計元へ適切な薬事アドバイスを提供する 薬事申請資料の作成・レビューを行い、承認申請業務を推進する 既存製品の承認維持管理を行う 薬事管理・規制対応 QMS/FMR登録業務、薬事評価、販促資材レビューなどの薬事管理業務を統括する 厚生労働省、医薬品医療機器総合機構、認証機関との折衝および良好な関係構築を行う PMS（市販後監視）チームおよび品質保証チームと連携し、規制課題への対応や継続的なコンプライアンス活動を推進する プロセス改善・業務変革 AIおよびデジタル技術を活用した業務効率化・プロセス改善を推進する グローバルチームと連携し、PSQ全体に影響を与える業務変革プロジェクトをリードする チームメンバーの育成および組織能力向上に貢献する
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
MAIN RESPONSIBILITIES / DUTIES JOB POSITION PURPOSE • Act as the Amyloidosis team lead and line manager, leading a team of MAS. Shape the local strategy and ensure the delivery of scientific‑medical expertise and exchange with leading
JOB DESCRIPTION: About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you
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 Description: Business Overview Rakuten Groups fundamental management philosophy is to empower people and society through innovation. We provide over 70 diverse services, including EC services such as the internet shopping mall Rakuten Ichiba and the
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE The MAS role family comprises a variety of medical scientific specialties, such as BU Medical and field based Medical. Be the Pfizer Japan medical scientific point of contact for
MAIN REPONSIBILITIES / DUTIES JOB POSITION PURPOSE The MAS role family comprises a variety of medical scientific specialties, such as BU Medical and field based Medical. Be the Pfizer Japan medical scientific point of contact for
Job Description: Department Overview The Global Travel Management Department of Rakuten Travel is accelerating Rakuten Travels global business expansion, particularly services for international users traveling to Japan and future global business development. Through travel services centered
About us BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse
We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes
Pricing Manager Are you ready to shape how millions of patients in Japan access breakthrough treatments in obesity and cardiovascular care? This is a rare moment to join a market access team just as two of the
Basic Purpose of the Job The Clinical Program Leader assumes Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Programme Team Leader. The Clinical Program Leader
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Red Nucleus is hiring a Senior Manager / Associate Director, RegOps to join our global team. This role will be fully remote. Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider
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 Description: Business Overview Ad & Media Company leads the Advertising Business, one of the core growth pillars of the Rakuten Group. By maximizing the power of the Rakuten Ecosystem and leveraging data and technology, we
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