Senior Manager, CMC Regulatory (CMC Senior Expert, CMC Regulatory)

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From Bristol Myers Squibb’s original posting

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. 役割と責任 【共通】 • 各段階においてリスクアセスメントを実施し、必要に応じてリスク管理計画を立案・実行する。 • CMC規制の観点から規制上の議論を行い、開発戦略に関する適切な情報を提供することでクロスファンクショナルチームに貢献する。 • グローバルチームを含む関連部門に対し、規制・技術上のアドバイスを提供する。 • 自身の知識・スキルを活かし、チームメンバーをリード・支援する。【開発段階】 • 治験届（CTN）に必要な情報を提供し、必要に応じてグローバルチームと連携し、提出タイミングを考慮したCTN関連添付文書を作成する。 •…