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 ...

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。 · ...

影響力ある規制戦略を推進する · グローバルチームと協力し、ヘルスケアソリューションを形成 · 新薬開発および当局との会議に向けた規制戦略の策定 · J-CTDの作成および社内レビュー管理 · ...

世界的製薬企業における規制戦略/開発スペシャリストの仕事では、革新的な医薬品のための影響力ある規制戦略を推進し、グローバルチームと協力してヘルスケアソリューションを形成します。 · 新薬開発および当局との会議に向けた規制戦略の策定 · J-CTD作成および社内レビュー管理 · ...

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 ...

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takadas Privacy Notice and Terms of Use. · ...

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 ...

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 ...

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. · ...

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

+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 ...

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 ...

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 ...

We are seeking a RegulatoryAffairs Specialist to join our team at JohnsonandJohnson.The successful candidate will be responsible for maintainingand managing regulatory approvals for pharmaceutical products including surgical suturesand adhesives. · ...

Leveraging advanced kinetic analysis to drive efficient drug development · and maximize compound value. · ...

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 ...

+ · The company seeks an experienced professional for its regulatory affairs team responsible for maintaining management of Japan general surgery field products including sutures tissue adhesives etc. ...

+This role involves maintaining regulatory approvals for general surgery products including sutures and tissue adhesives. · +Promptly managing regulatory compliance activities across various regions. · Establishing strong relationships with key stakeholders within local authoriti ...