JOB DESCRIPTION: Regulatory Affairs Manager（RAマネージャー） モレキュラー事業部（Molecular Diagnostics） 職務概要 Regulatory Affairs Managerは、日本国内における体外診断用医薬品（IVD）および関連医療機器の薬事戦略を統括し、事業目標の達成に向けた薬事機能全体のマネジメントを担う。 本ポジションは、新製品の開発・上市に向けた薬事戦略の立案から承認取得、保険適用および保険収載戦略の策定・推進、既承認品の維持管理、規制対応、QMS適合性調査対応に至るまで、製品ライフサイクル全体にわたる薬事活動について責任を有する。 また、PMDAおよび厚生労働省との主要な窓口として、承認申請、規制戦略、保険適用・診療報酬に関する当局対応および交渉をリードし、製品価値の最大化と患者アクセスの向上を推進する。 さらに、グローバル薬事チーム、品質保証、マーケティング、サプライチェーン等の関係部門と連携し、承認戦略と保険戦略を統合した市場導入計画を推進することで、モレキュラー診断事業の持続的成長に貢献する。 加えて、薬事チームの人材育成、組織能力の強化および業務改善を通じて、高いパフォーマンスを発揮する薬事組織の構築と継続的な成長を主導する。 _ 主な職務内容（Responsibilities） 薬事戦略および事業支援 モレキュラー事業部における薬事戦略の立案・実行 新製品導入および既存製品拡販に向けた規制戦略の策定 承認取得から保険適用までを見据えた統合的な薬事戦略および市場アクセス戦略の立案 国内外の経営層および事業部門に対する薬事リスク・機会の分析および提言 薬事観点から事業計画、製品ポートフォリオおよび上市計画を支援 国内外の規制・政策変更に伴う事業影響評価および対応方針の策定 関連学会、業界団体および行政機関との関係構築を通じた事業機会の創出 モレキュラー診断およびコンパニオン診断薬領域における規制・市場アクセス動向の把握と事業戦略への反映 承認申請・保険適用および当局対応 新規製品の承認申請、認証および届出戦略の統括 PMDAおよび厚生労働省との主要窓口としての折衝 PMDA対面助言、各種相談および照会事項対応のリード 承認取得までのプロジェクトマネジメント 保険適用および保険収載戦略の立案・実行 厚生労働省、関連学会および社内関係部門と連携した保険収載・診療報酬に関する交渉の主導 承認戦略と保険戦略を統合した市場導入計画の策定 保険適用に必要となる臨床的・分析的エビデンス戦略の策定および推進 行政通知、関連法規および規制要件に関する当局協議・交渉 コンパニオン診断薬における医薬品開発パートナーとの薬事戦略連携
About Rescale Rescale is pioneering the future of engineering and scientific discovery. As the leader in digital engineering, we’re transforming how products are developed—through intelligent automation, applied AI, data management, and the integration of the world’s
Description Would you like to be involved in applied cutting-edge science? Are you interested in contributing to the translation of exciting new discoveries into useful products? Do you want to be part of an interdisciplinary and
The Opportunity: Develops and executes business development strategies, serving as primary contact for strategic alliances and key partners. Drives cross-functional collaboration to align deals with business goals. Mentors less experienced team members. The Head of Bioprocessing,
General Information Job Advert Title: Scientist I Location: Tsukuba,Ibaraki Division: Cell and Gene Therapy Research Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science into VALUE for
Summary This role will focus on managing and accelerating the performance of sales territories through coordinated efforts between sales channel business partners (distributors and dealers) and the ONT Sales team in Japan. This position will be
General Information Job Advert Title: Scientist I, Gene Therapy Vector Engineering / 遺伝子治療ベクター開発研究員 Location: Tsukuba,Ibaraki Division: Cell and Gene Therapy Research Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to
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Description This position is dedicated to systematically capturing and recording the hard-to-document knowledge (tacit knowledge) inherent in sequencing experiments, through hands-on experimental work. At the Sequencing Section (SQC) of the Okinawa Institute of Science and Technology
We’re seeking a Computational Chemist to join us in our mission to transform the discovery of therapeutics and materials! Our drug discovery group of over 60 scientists includes designers, modelers, computational chemists, medicinal chemists, crystallographers, biochemists,
We’re seeking a Computational Chemist to join the Schrodinger Therapeutics Group as a Senior Scientist in our mission to transform the discovery of therapeutics and materials! Our drug discovery group of over 60 scientists includes designers,
The individual is expected to professionally and effectively complete the day-to-day tasks required, across a number of disciplines, via the telephone, zoom, email or social media using ONT sales tools and resources. Combined with their personal
JOB DESCRIPTION: Job Description Position Overview The International Project Manager, Japan oversees a portfolio of complex transformation projects, coordinating multiple workstreams and applying best practices to ensure their projects meet business objectives and are accomplished on
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to
About the job Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam DAngelo, Larry Summers, and Jack Dorsey. Position: Atomistic
About the job Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam DAngelo, Larry Summers, and Jack Dorsey. Position: Atomistic
About the job Mercor connects elite creative and technical talent with leading AI research labs. Headquartered in San Francisco, our investors include Benchmark, General Catalyst, Peter Thiel, Adam DAngelo, Larry Summers, and Jack Dorsey. Position: Preclinical