Description
**Group Purpose**
The Compliance and Labeling Group is responsible for MAH business license, Three-supervisors’ committee (Sanyaku-kaigi), Labelling, Foreign Manufacturer Accreditation/ Foreign Manufacturer Registration (FMA/FMR), periodic GMP inspection, and other activities to ensure compliance the Act on Pharmaceutical and Medical Device(PMD) Act. and to support the execution of the pharmaceutical business.
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薬制・添付文書部は、医薬品医療機器等法に基づく製薬事業遂行を支えるため、MAHビジネスライセンス、三役会議、ラベリング、外国製造業者の登録、定期GMP適合性調査などを担当し、関連法規制の遵守に貢献します。
**Job Summary**
+ Support the operation of the Three Supervisors’ Committee (Sanyaku-kaigi) including preparation of materials and meeting documentation.
+ Excuse MAH license management and regulatory compliance activities in accordance with the PMD Act.
+ Perform labeling-related tasks such as Package Insert (PI), Instructions for Use (IFU), and packaging components.
+ Carry out FMA/FMR and GMP-related application and maintenance activities.
+ Prepare regulatory submission materials and support communication with health authorities in coordination with internal functions.
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+ 三役会議（Three Supervisors’ Committee）の運営補助や関連資料作成
+ 医薬品医療機器等法に基づくMAHライセンス管理や規制対応業務の実施
+ 添付文書（PI）、取扱説明書（IFU）、包装資材等のラベリング関連業務の遂行
+ FMAやGMP関連の申請・管理業務の実施
+ 当局対応に必要な資料作成や社内関連部署との調整サポート
**Key Activities**
+ Perform MAH-related tasks: preparation and documentation for the Three Supervisors’ Committee, SOP/document management, inspection readiness, and training support.
+ Execute product labeling tasks:
+ Support M1.8 creation during development.
+ Revise PIs and review promotional materials in post-marketing.
+ Support FMA/FMR acquisition and renewal: application, registration, and communication with MHLW/PMDA.
+ Contribute to GMP inspection preparation in collaboration with Quality team.
+ Manage package component artwork (PI, IFU, labels, etc.) using an internal system in coordination with Global Labeling, Supply Chain, QA, Commercial/Marketing, and vendors.
+ Handle import certificates (Yakkan) via Nippon Automated Cargo and Port Consolidated System (NACCS) and export notifications in a timely manner.
+ Conduct regulatory review of promotional and non-promotional materials
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+ MAH関連業務の実務担当：三役会議の準備・記録、SOP文書管理、規制当局査察への準備支援、社内研修の実施サポート
+ 製品ラベリング業務：
+ 開発段階でのM1.8作成サポート
+ 市販後における添付文書改訂
+ FMA/FMR取得・更新業務：厚労省/PMDAとの申請・登録、更新管理
+ GMP査察対応：品質部門と連携し定期査察に必要な業務をサポート
+ パッケージ資材（PI、IFU、ラベル等）の版下作成や社内システム等を用いたプロセス管理
+ 輸入証明書（薬監証明）の取得・管理、輸出入関連手続き
+ 販促資材や非販促資材の規制レビュー
**Knowledge and Skills**
+ Practical knowledge of the PMD Act.
+ Knowledge and experience in PI, IFU, and labeling-related operations.
+ Basic communication skills for interactions with health authorities (PMDA, etc.).
+ English proficiency for document preparation and email communication.
+ Basic IT skills (business applications, document management systems).
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+ 医薬品医療機器等法に関する実務知識
+ 添付文書、取扱説明書、ラベリング関連業務の知識と経験
+ 規制当局（PMDA等）との折衝・申請に必要な基本的なコミュニケーションスキル
+ 英語での文書作成・Eメールコミュニケーション能力
+ 基本的なITスキル（業務アプリケーション、文書管理システム活用）
**Education & Experience**
+ Bachelor’s degree (preferably in a scientific field).
+ At least 5 years of pharmaceutical industry experience in regulatory-related activities.
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+ 学士号（理系分野が望ましい）
+ 製薬業界での薬事規制関連業務経験（目安：5年以上）
