Position Summary The Associate Director of Regulatory Affairs-Chemistry, Manufacturing, and Controls (RA-CMC) in Japan will be responsible for leading and providing Japan CMC regulatory support for the clinical and commercial product portfolio, which means managing of filing the highly strategic documents
Are you experienced in CMC regulatory affairs or in generating high-quality documentation related to drug manufacturing and marketing approval/maintenance? Do you have a strong understanding of CMC requirements in Japan? We are seeking a CMC Expert to join our team and
安全管理責任者 - Safety Control Manager/ GVP Controller Who we are: At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for
For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases
Position Purpose Achieve successful filing and approval of the following CMC dossiers in Japan with sophisticated CMC regulatory strategies. NDA for Vaccines, Biologics and Biosimilars Life cycle management of Vaccines, Biologics and Biosimilars Post-approval change management of Vaccines, Biologics
JOB DESCRIPTION Job Title: Quality Assurance Manager Department / Cost Center: External Quality / 687 Reports to (Job Title): Associate Director, In Market Quality Job Code: Location: Japan office Date Prepared: 01AUG2024 SUMMARY DESCRIPTION State the
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical
Job Description Summary ・BSの薬事開発から承認取得及び市販後のメンテナンスまでの薬事戦略を立案の上で実行する。 ・BS医薬品の上市、メンテナンス及び安定供給に貢献できるマネジャー職 ・BSの薬事業務について国内及びGlobal関係者をリードする Job Description Major accountabilities: 1) 複数のBSプロジェクトの進捗に貢献する 2) 他のメンバーが担当するBSプロジェクトをサポートする 3) BSのPMDA相談の成功及び承認取得のための薬事戦略案を策定し、Global teamに提示し、Global teamの計画と統合する 4) BSのGlobal team及びSKK関係者をリードし、PMDA相談や国内承認申請（一変を含む）の準備を進め実施する 5) 薬事関連業務について、Global 及び 国内の社内関係者をリードして業務を取りまとめ、業務目標を達成する 6) 規制当局（PMDA、MHLW等）との交渉をリードする 7) 外部委託先を管理する Key performance indicators: ・製薬会社で5年以上の薬事経験（開発薬事又はCMC薬事）を有する又は 生物製剤のCMCに関する日本の規制に精通している • プロジェクトの状況と日本の規制を考慮した薬事戦略の提案ができる • ネゴシエーションスキルがある（国内及びGlobal関係者に対して）
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.
