職務の目的 Dysonでは、既成概念にとらわれず、失敗を恐れずに挑戦する姿勢が奨励されています。私たちは創造的で、協力的で、実践的、そして情熱的です。何より、自分たちの仕事に大きな誇りと熱意を持っています。 私たちは日々業界の壁を越え、世界水準の製品を開発するために挑戦し続けています。これを成功させるためには、コンプライアンスを念頭に製品設計を進める必要があります。つまり、企画の早い段階から設計チームと連携し、市場参入の障壁を取り除きます。 グローバル プロダクト レギュレーション＆コンプライアンスチームは、製品開発をサポートし、グローバル市場参入を実現するための専門知識と助言を提供します。 本ポジションでは、日本を拠点にした薬事分野の高度な知見と化粧品医薬部外品規制の実務経験を有する規制関連のプロフェッショナルを募集しています。当社グローバルレギュラトリーチームの日本の薬機規制エキスパートとして活躍いただきます。 この職種は、日本の薬機規制コンプライアンスの全責任を担うシニア・インディビジュアル・コントリビューター職であり、規制面での窓口となり、自立して担当プロジェクトの開発から上市、上市後サポートまでを管理し、PMD法への完全な適合を確保します。 主な担当は日本ですが、海外チームと連携する形でグローバルな案件にも参画します。 本ポジションは日本のオフィス勤務で、英国のシニアレギュラトリーマネージャーへのレポートとなります。 主な業務内容（アカウンタビリティ） 日本における医薬部外品規制コンプライアンス 薬機法に基づく内部規制エキスパートとしての役割 厚生労働省（MHLW）／医薬品医療機器総合機構（PMDA）／業界基準等の要件の解釈と適用 製品の分類（化粧品か医薬部外品か）および適切な効能表現の助言 日本向けラベリングの策定、レビュー、承認 日本の薬機法関連製品に関する届出・申請・設立義務（GMP、GQP、GVP）の管理 規制対応の文書対応や査察対応の準備支援 上市後の法的コンプライアンス維持、該当官公庁への義務報告を含む 日本の化粧品規制対応 日本の化粧品規制（厚生労働省・PMDA）の社内専門家としての役割 日本のポジティブ／ネガティブリスト及び基準に基づく成分の適合性確認 成分適合性および安全性の根拠確認 製造販売業／輸入業許可と必要な製品届出の支援 化粧品のラベリングと効能表現に関する規制指針の提供 プロジェクト主担当・チーム貢献 グローバルチームの日本地域薬機規制スペシャリスト 地域レギュラトリースペシャリストと連携しつつ、担当グローバル規制プロジェクトを自律的に管理 製品情報ファイルの管理、ラベリングのコンプライアンス確認 必要な登録・届出の完了 コンプライアンス要件をチームに明確に伝達 プロジェクト推進のために改善策の提案や評価への参画 チームのトランスフォーメーション施策・変革プロジェクトへの参加・主導 必要に応じてチームメンバーの指導・メンタリング 規制インテリジェンス 日本における情報収集のさまざまな手法への理解
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