規制戦略のリードおよびPMDA/MHLWとの対応、神経科学および精神医学プロジェクトにおけるグローバルな協力 · 日本における規制戦略の主要窓口としての役割 · PMDA/MHLWとの連携および申請書類の作成 · グローバル規制チームへの日本特有の情報提供 · 共同販促におけるコンプライアンスの確保 · CTDモジュール(モジュール1およびモジュール2の支援)の作成・編集 · 国内査察の監督およびコンサルタントの管理 · 提携製品の市販後薬事活動の支援 · 製品文書(添付文書、DMFなど)の維持管理 · 当局および業界からの規制情報の収集 · PMDA信 ...

アジア・欧州など75以上の国と地域に展開する製品に関与 · 革新的で患者中心の製品を提供するヘルスケア企業。世界75以上の市場で展開しており、科学的根拠に基づいた製品ポートフォリオを持つ成長企業です。 · 日本市場における薬事戦略の立案・実行 · 製品登録・維持管理、申請スケジュールの策定と進捗管理 · 薬事関連法規(PMD Act等)の情報収集と対応 · 新製品導入に向けた薬事支援、技術情報の収集・提供 · グローバル・ローカルプロジェクトへの参画・支援 · ...

グローバルな動物医療の革新に貢献できる · ダイナミックな国際的環境で働けるチャンス · 日本における動物用免疫製剤の登録プロセスに参加 · 国内提出用の登録申請書類の作成・レビュー · ...

グローバルリーディングivd企業のraシニアスペシャリストに参加して、革新的な製品の規制戦略を推進します。 ...

世界的に事業を展開する大手医療機器メーカーです。 · 革新的な技術を活用し、医療業界に高品質な製品とソリューションを提供しています。 · ...

The CMC RA Manager will lead and manage CMC regulatory activities, develop and implement CMC registration strategies, and support the development of the CMCRA team. The ideal candidate will have +10 years of practical experience with CMC-related roles, experience drafting and com ...

Lead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines. Develop and implement CMC registration strategies related to CTNs, NDA ...

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. We are deepening our commitment to elevating the dialysis experience thr ...

FP&A and Reporting Manager job opening at a biotech company in Tokyo. The company is developing innovative treatments for cancer and is looking for a skilled FP&A professional to lead the annual budgeting, quarterly forecasting, and long-term financial planning processes. · Lead ...

Director, Search & Evaluation, Business Development JAPAC · 日本から世界にイノベーションを届け、日本発の国際的なリーディングバイオ企業となることをビジョンとしています。 · Lead the end-to-end evaluation of potential assets—including scientific, commercial, and valuation model analysis—to inform CEO-level decisions. · Manage in-/out-l ...

+Job summary · A Senior Technical Consultant position is available at Elanco to provide academic information to customers and internal departments while improving customer satisfaction. · + Sales representatives training, field activities support for sales activities. · Email or ...

We are seeking a strategic business leader to drive growth for a leading healthcare solutions provider in Japan. This role offers the opportunity to shape the business unit strategy, lead cross-functional teams, and build strong partnerships with pharmaceutical clients and key st ...

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. · Contract content, pha ...

As a Senior Technical Consultant at Elanco, you will be responsible for providing academic information to customers and internal departments, and improving customer satisfaction. You will also be involved in sales training, field activities, customer service, and academic informa ...

Direct Procurement position at a major global pharmaceutical company. Collaborate with Category Management to create and refine global Category Strategies. Implement Commodity Strategy on local level and execute sourcing activities within markets. · ...

Director, Group Reporting position at a global bio-pharmaceutical company group focused on exploring and developing new drug candidates. The company aims to provide high-quality medicines and contribute to disease treatment and health maintenance. · Plan and execute digital trans ...

Leveraging the latest insights in pharmacokinetics (PK) and pharmacodynamics (PD), we apply advanced kinetic analysis to drive efficient drug development, regulatory registration and maximize compound value. · ...

Johnson & Johnson MedTech is expanding in multiple business areas, including Orthopaedics, Surgery, Electrophysiology, and Neurovascular. This position is for a Regulatory Affairs Manager in the Orthopaedics area, reporting to the relevant RA manager. · Plan, prepare, and execute ...

This is a Japanese-speaking technical support role located in Japan. ...

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. · Johnson & Johnson believes health is everything and empowers us to build a world where complex diseases are prevented, treated, and ...

This is a Manager, Medical Customer Care GMT Business Unit position at Alexion Japan. The job involves working with medical professionals and being the primary point of contact for Alexion. The role requires building good relationships with medical professionals, providing custom ...