承認取得した新薬など:[Shire Japan→武田薬品工業(2018.2~2024.7); Moderna IM Vaccine (40% of M1.2(Excipients), English; May,2021), Buccolam*(Sep,2020), Firazyr Inj*(Sep,2018), PCA&MCN of Gammagard/ FEIBA/Agrylin[Biogen (2014.3~2017.12); CMC] Spinraza Inj*(July,2017), Tecfidera Capsules*(Dec,2016), Eloctate Inj(Nov,2014), Tysabri Inj*(M1.2)[sanofi-aventis (2000~2012); CMC] Lixisenatide Inj, Vaccine Japan Combo, Rasburicase Inj, Thymoglobuline Inj*: Ketek small Tab, Arava Tab, Amiodaron Inj[RPR (1983~1999); CMC/Human ADME] Menorest Patch (CMC), Rilutek Tab*(CMC/Human ADME), Taxotere Inj (CMC/Analysis of PI plasma/urine samples), Enoxaparin Inj (CMC), Pentamidine Isethionate Inj*(CMC), Ketoprofen IM Inj (CMC/BE study), Ketoprofen suppository (Clinical/CMC)*: 8 Orphan drugsI can prepare M2.3 and M1.2 in Japanese and English, simultaneously.M1.2 is accurately translated into English based on the latest JP English version.
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嘱託社員 And株式会社アールピーエムKoto City, Tokyo, Jp -
シニアマネージャー/薬事部ロバートウォルターズ Jul 2024 - Present日本 東京都
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Cmc薬事部 Lcmグループ武田薬品工業(株) Feb 2018 - Present大阪府
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Ra Cmc武田薬品工業(株) Apr 2022 - Jul 2023日本 東京都 23 区内CMCのCTD作成よりも申請書のメンテナンス(一変申請、警備変更など)業務が求められている。
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Cmcグループ マネージャーシャイアー・ジャパン㈱ Feb 2018 - Oct 2020日本 東京都 23 区内武田RA-CMCに統合
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CmcマネージャーBiogen Idec Mar 2014 - Dec 2017コレド日本橋In charge of Small molecules: Tecfidera, Spinlaza (Antisense Oligonucleotide), FampyraSupport Biological products: Tysabri, Avonex, (Eloctate, Alprolix) -
Cmcマネージャーバイオジェン・ジャパン株式会社 Mar 2014 - Dec 2017
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Fresenius-KabiRa&Qa Manager Jul 2012 - Feb 2014Shinagawa, TokyoPreparation of CMC dossiers of Generic of Taxotere, Irinotecan HCl
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Sanofi-AventisManager Apr 1983 - Jun 2012Author of CMC dossiers for Taxotere (1994:1st NDA in the world), Rilutek (1995), Enoxaparin (1990), Ketek small Tab (200X), ・・・Lixisenatide (2012)Human PK analysis: Taxotere PhI, BE of Ketoprofen IM
Frequently Asked Questions about 又邊弘之
What company does 又邊弘之 work for?
又邊弘之 works for 株式会社アールピーエム
What is 又邊弘之's role at the current company?
又邊弘之's current role is 嘱託社員 and.
What schools did 又邊弘之 attend?
又邊弘之 attended 東京理科大学.
Who are 又邊弘之's colleagues?
又邊弘之's colleagues are Roger Bailey Fiirsm, Joan Bailey.
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