Job Description SummaryGE HealthCare Japanでは、医療機器の薬事業務を担当いただく Sr. Associate Specialist, Regulatory Affairs を募集しています。 本ポジションは、クラスⅡなどの特定モダリティ主に能動デバイス医療機器における薬事業務を担当し、直属の上司またはプロジェクトリーダーの指導のもと業務を遂行します。申請プロジェクトの進捗については、必要に応じて関係者へ報告を行います。 また、規制当局や業界団体と連携しながら業務を進めるとともに、業務遂行にあたりビジネス上の重要な要素および常に変化する規制要件を理解することが求められます。 GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock
JOB DESCRIPTION: MAIN PURPOSE アボットメディカルジャパンが取り扱う循環器領域の医療機器（主にクラスⅣの高度管理医療機器）において、薬事担当者として高い専門性と自立性をもって薬事業務を主導し、製品の承認取得およびライフサイクル全体にわたる規制対応を推進します。 シニア～プリンシパルレベルの 個人貢献型プロフェッショナル として、複雑性の高い案件や関係部門・規制当局との調整をリードする役割を担います。 MAIN RESPONSIBILITIES - 当社製品における承認申請、変更申請、定期報告等の作成・提出の主担当 - 規制当局（PMDA等）との照会対応、折衝を通じた承認取得の推進 - 製品ライフサイクル全体（開発～上市後）における薬事対応のリード - 社内関係部署（研究開発、品質、製造、マーケティング等）との横断的な調整および助言 - 規制要件・ガイドラインの解釈を踏まえた薬事方針の検討・提案 - グローバル薬事チームとの連携、情報共有、英語での会議・文書対応 （プリンシパル相当の場合） - 組織内における薬事の専門的相談窓口 - 若手薬事メンバーへの助言・支援 QUALIFICATIONS 必須要件 - 理系学士卒以上（修士・博士歓迎） - 医療機器薬事の実務経験：5年以上 - クラスⅢ／Ⅳ 医療機器に関する薬事経験
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 DESCRIPTION: Primary Function Provides global or regional leadership for a particular regional or global clinical program. Ensures design and execution of high quality clinical studies to ensure safety and effectiveness of the company’s products. Manages
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)
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)
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 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
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)
About Convatec Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound
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
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)
Overview Governments across the region are rapidly advancing cyber regulatory frameworks, strengthening protection of critical infrastructure, and investing in secure digital services for essential functions and the broader economy. The Microsoft Global Affairs team for Asia is seeking