患者さんのためにあなたの力を発揮してください · 日本におけるCMC規制戦略の実行 · 新薬承認申請書類の作成と提出 · GMP事前査察の申請業務 · 輸入・製造・販売に関する課題の分析と解決支援 · 規制文書の品質管理 · 製造販売承認の維持と更新 · 理系学士または修士号を保有していること · 規制業務または品質管理の経験が5年以上あること · 国際的な業務経験がある方歓迎 · 規制当局との関係構築経験 · 英語でのコミュニケーション能力 · 科学的知識と文書レビュー能力 · ...

患者さんのためにあなたの力を発揮してください · 私たちは、情熱的で柔軟性があり、協調性のあるCMC薬事担当を募集しています。 · このポジションは、東京都にある当社オフィスを拠点とするチームの一員として勤務していただきます。 · ...

The Associate Principal Scientist, Regulatory CMC Japan will be accountable for assessment of changes for regulatory impact, development of Japan CMC strategy, preparation of CMC documentation and execution of post-approval CMC supplements and new product registrations for the en ...

To conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA). To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval. · ...

To conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA). To prepare application dossiers for CMC part and to communicate with HA appropriately to contribute in obtaining regulatory approval. · ...

Coordinate CMC regulatory strategy activities for assigned projects throughout development phases. Manage CMC Regulatory relationship with Global CMC to ensure alignment between Japan-Global CMC strategy. · Lead CMC regulatory strategy development for assigned projects ensuring C ...

The CMC Regulatory Strategy Manager will coordinate the CMC regulatory strategy activities for assigned projects, manage the CMC Regulatory relationship with Global CMC, and execute CMC Module finalization of J-NDA. The role will also lead the development of CMC regulatory strate ...

BeOne is seeking an experienced regulatory professional to manage and evaluate regulatory projects. · ...

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the glob ...

The Director of Global Regulatory Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for developing and implementing global CMC regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products. · Lea ...

Drive the Future of AAV Gene Therapy. A Japan-based stealth biotechnology venture is developing a next-generation AAV gene therapy for vision restoration. · Lead mid-to-late phase CMC workstreams for AAV vector development · Drive process characterization, validation readiness, a ...

Join our dynamic team as a CMC (chemistry, manufacturing, and controls) Expert, where you will play a pivotal role in shaping regulatory strategies and ensuring high-quality submissions to authorities like PMDA/MHLW. Leverage your expertise to collaborate with global teams, shari ...

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 ...

Join our dynamic team as a CMC Expert, where you will play a pivotal role in shaping regulatory strategies and ensuring high-quality submissions to authorities like PMDA/MHLW. · Prepare high-quality J-QOS documents, application sheets, and responses to inquiries from PMDA/MHLW in ...

Johnson & Johnson is seeking an Assoc Dir APAC Regulatory Leader to join the APAC Regulatory Affairs team. The Senior Manager APAC Regulatory Leader is a member of the Global Regulatory Affairs organization. The position resides in the AP Region and is responsible for working wit ...

Local Representative for Regulatory Affairs, Local Compliance in Japan. · ...

Strategic, analytically minded professional with a passion for bridging scientific insights and cutting-edge technology. Collaborate with scientists, product managers, and engineers to transform complex scientific data into actionable outcomes. · Investigate diverse customer data ...

We are catalyzing the Scientific AI revolution by designing and industrializing AI-native scientific data sets, which we bring to life in a growing suite of next gen lab data management solutions, scientific use cases, and AI-enabled outcomes. · Design and implement extensible, r ...

Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. · As th ...

Genmab is a global biotechnology company that aims to improve patients' lives through innovative antibody medicines. We are a passionate and innovative team that has developed a next-generation antibody technology platform over 25 years, using translational science, quantitative ...