Regulatory Affairs Mgr (Regulatory Labeling Mgr)

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）