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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

CMC薬事シニアアソシエイト(FSPモデル)

Job ID R0000039251 , Japan

ポジション概要

本ポジションは、ParexelのFSPモデルに基づき、特定の製薬企業様専任として配属されます。製薬企業様の日本薬事チームの一員として、 、CMC(Chemistry, Manufacturing and Controls)関連の規制業務サポートを行うポジションです。

勤務形態:

基本的に在宅勤務(必要に応じて製薬企業様のオフィスに出勤)

主要な職務内容

規制申請業務

  • グローバルCMC変更申請書(CTD m1/2/3)の作成

  • 年次報告書および更新申請のCMC部分の作成

  • グローバル製造販売承認申請(MAA)の展開支援

  • 入札申請書類のCMC部分の作成

  • GMP関連申請(製造所登録等)のサポート

  • 規制当局からの照会事項への対応

変更管理

  • 製品変更に伴う影響評価の実施

  • 各国規制要件の確認と調整

  • 変更管理文書の作成と管理

プロジェクトマネジメント

  • クライアントとの主要窓口としての機能

  • プロジェクト計画の立案と進捗管理

  • 品質とタイムラインの確保

  • リスク管理とエスカレーション対応

  • プロジェクト財務管理(予算、収益予測等)

  • 小規模プロジェクトのリード、または大規模プロジェクトのワークストリームリード

必須要件

学歴

  • 化学/科学または技術分野の学士号以上

経験

  • 製薬またはバイオテクノロジー業界での実務経験5年以上

  • レギュラトリーアフェアーズ(CMC分野)での実務経験5年以上

望ましい経験・知識

  • ICH-CTD形式での申請書作成経験

  • 複数国での規制申請経験

  • GMP関連知識

  • 医薬品製造プロセスに関する理解

  • 規制当局との折衝経験


#LI-REMOTE

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