- 革新的な医薬品のための影響力ある規制戦略を推進
- グローバルチームと協力し、ヘルスケアソリューションを形成
企業情報
患者の生活改善に取り組む世界的製薬企業
革新と最先端の医薬品開発に注力
国際的な交流を伴う協調的で包括的な企業文化
継続的な学習とキャリア成長の機会
全市場での規制遵守と卓越性を重視
医療に実質的な影響を与える社員を支援
倫理基準と持続可能な取り組みで高い評価
職務内容
新薬開発および当局との会議に向けた規制戦略の策定
日本版共通技術文書(J-CTD)の作成および社内レビュー管理
治験届(CTN)や主要な規制申請(J-NDA、J-sNDA)の主導
当局からの照会対応をクロスファンクショナルチームと調整
開発品および市販品の規制活動の遵守・維持を確保
GRTにおけるJAPC代表としてプロジェクト戦略、タイムライン、リスク軽減計画を定義
規制変更や競合状況を監視し、プロジェクトへの影響を評価
商業部門・メディカル部門の要請に応じて添付文書改訂活動を主導
承認加速のため、当局との建設的な議論に積極的に参加
社内関係者に規制の専門知識とガイダンスを提供
理想の人材
製薬企業での研究開発または薬事業務の経験
新薬開発および規制審査プロセスに関する深い知識
優れた論理的思考、交渉力、コミュニケーション能力
自立して業務を遂行し、チームで協働できる能力
日本語ネイティブレベル、英語はTOEIC800点以上
主体的で結果志向、変化する規制環境への適応力
What's On Offer
革新的治療薬の規制戦略に影響を与える機会
クロスファンクショナルな協働を伴うダイナミックなグローバル環境
競争力のある報酬・福利厚生パッケージ
専門的な成長とキャリアアップの機会
世界中の患者の健康改善に貢献する使命感ある組織の一員
Contact: Zach Itozu
Quote job ref: JN
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Tokyo Michael Page世界的製薬企業における規制戦略/開発スペシャリストの仕事では、革新的な医薬品のための影響力ある規制戦略を推進し、グローバルチームと協力してヘルスケアソリューションを形成します。 · 新薬開発および当局との会議に向けた規制戦略の策定 · J-CTD作成および社内レビュー管理 · ...
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