Tokyo The businesses of Merck KGaA, Darmstadt, Germany Full time

ポジション: Life Science Regulatory Management

  :  Regulatory Specialist

 レポートライン:  Regulatory senior Manager日本人

 勤務先:  東京勤務(週2日 在宅ワーク可)

職務内容:

以下の業務をRegulatory Expertと共に業務を行います。

・DMF新規、変更及び維持管理(原薬及び添加剤等)と製販への連絡

・外国製造業者認定の代理人としての業務

・体外診断用医薬品/医療機器 承認申請維持管理

・申請書内容と製造実態との定期的点検

・PMDA相談

・GMP適合性調査対応

・輸入確認(薬監証明)

・法改正動向確認及びグローバル薬事への展開

応募要件:

・薬剤師免許取得

・日常的な英文メールのやりとりに拒否反応が無いこと。

・他部署と積極的にコミュニケーションが取れること。

・医療業界で、薬事申請、品質保証又はCMC経験がある方は歓迎します。



  • Tokyo EMDGroup

    メルクと一緒に、あなたの力を発揮しよう · 冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう · ...


  • Tokyo The businesses of Merck KGaA, Darmstadt, Germany Full time

    Life Science Regulatory Management、レギュラリースペシャリストとして業務を行う。東京勤務、週2日在宅ワーク可。 · ...


  • Chiyoda Real

    当社は革新的な医療技術を通じて医療現場の課題解決に貢献するグローバルメドテック企業です。 · 本ポジションでは医療機器のISO13485に基づく品質マネジメントシステム(QMS)の運用および改善を担当いただきます。QMS文書を作成・改訂し続続的なプロセス改善を行うことができます。また手順書を作り規制対応を行い、および輸送管理安全管理(Vigilance)まで幅広い領域で仕事をすることができます。 · ...


  • Minato BD Nogales Norte

    BDは、ヘルスケア分野における多様なニーズに応える医療技術、デバイス、実験機器を開発する世界をリードする医療技術企業です。感染症の撲滅と治癒を目指す戦いにおいて最先端の研究を提供し国内外の人々に画期的な医療・バイオテクノロジーサービスへのアクセスを向上させるという私たちの使命で、私たちが求めています。 · ...


  • Minato BD Nogales Norte

    当社のライフサイエンス※製品に関する薬事業務全般をご担当いただきます。具体的には以下の業務を担っていただきます。 · ...


  • Tokyo BD ¥25,000,000 - ¥35,000,000 per year

    · BD 안세요 전속,Waters Corp.첟BD안세요 전속,Waters Corp. ...


  • Minato-ku BD Full time¥1,584,000 - ¥2,442,000 per year

    薬事担当シニアマネージャーは、ライフサイエンス部門の薬事機能を統括し、バイオサイエンス事業部と診断ソリューション事業部の両方を統括します。体外診断用医薬品(IVD)関連規制を含む国内外の規制へのコンプライアンスを確保するための薬事戦略の策定と実行을担当します。 · ...


  • Tokyo BD ¥100,000 - ¥200,000 per year

    + · + · +h2+bJob summary/b/h2+pThe Senior Manager responsible for all aspects of regulatory affairs for BDB and DS./ppressible for all aspects of regulatory affairs for BDB and DS.+h2+bJob Description Summary/b/h2+pResponsible for all aspects of regulatory affairs +/pposition ove ...


  • Tokyo Merck Ltd. Full time

    Merck is seeking a Regulatory Affairs Expert to perform tasks such as preparation and submission of DMF for APIs and excipients. · ...


  • Japan Merck

    We are looking for a Regulatory Affairs Expert to join our team at Merck. · Maintenance of regulatory approvals for In Vitro Diagnostics (IVD) and Medical Devices. · ...


  • Tokyo, Tokyo Merck Life Science

    We are seeking a Regulatory Affairs Expert to join our team at Merck. · Maintain regulatory approvals for In Vitro Diagnostics (IVD) and Medical Devices, · Acting as an agent for Foreign Manufacturer Accreditation, · Preparation of DMF for APIs and excipients, · API Import licens ...

  • Regulatory Affairs

    4週間前


    Tokyo ZOLL Medical Corporation

    The Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparat ...

  • Regulatory Affairs

    1週間前


    Tokyo, Japan ZOLL Medical

    The Regulatory Affairs Manager is responsible for overseeing the preparation of regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities. This position will also oversee the preparat ...


  • Japan Colgate

    The Regulatory Affairs Manager supports the Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and statutes concerning development, manufacturing, distribution, marketing and sales of Hill's products in Japan. · ...


  • Japan Ceva Sante Animale $80,000 - $120,000 per year

    As a global leader in animal health Ceva Animal Health believes our success is linked to our passionate people researching developing producing and supplying innovative health solutions for all animals which contributes to the future of our diverse planet. · ...


  • Tokyo Regeneron Pharmaceuticals Full time¥9,000,000 - ¥12,300,000 per year

    We are now looking for in-country regulatory professionals to join our growing global regulatory team. · ...


  • Minato IQVIA

    This position requires the successful candidate to support the activities in RADDS Japan which includes contributing to the scoping, integrated proposal compilation, and delivery oversight of multi-disciplinary biopharmaceutical development advisory/clinical trial enablement proj ...


  • Tokyo, Tokyo GE HealthCare ¥6,000,000 - ¥12,000,000 per year

    We are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches, ...


  • Tokyo, Tokyo Planet Pharma

    A life sciences organisation is seeking a Regulatory Affairs Associate to provide hands-on administrative and documentation support to the Regulatory Affairs function in Japan. This role plays a key supporting role in regulatory project coordination, documentation quality, and su ...


  • Greater Tokyo Area IntelliPro

    Lead regulatory affairs in Japan for pharmaceutical products. · ...


  • Tokyo Digisailor Full time¥400,000 - ¥500,000 per year

    We are supporting a global life sciences organization in identifying an experienced Japan Regulatory Affairs Lead (CMC-focused). This role is responsible for defining and executing Japan-specific CMC regulatory strategies, ensuring compliance with Japanese regulations, and leadin ...