Job Description Summary
We are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting product launches, regulatory submissions, and post-market activities, while maintaining strong relationships with regulatory authorities in Japan.
You will collaborate closely with cross-functional teams, global stakeholders and partner companies, providing expert guidance on regulatory requirements and contributing to the success of innovative healthcare solutions.
グローバルヘルスケア企業にて、医薬品および医療機器の薬事戦略をリードするRegulatory Affairs Managerを募集しています。規制当局との連携を通じて、製品の上市、薬事申請、および市販後対応に関する戦略立案・実行を担っていただきます。
社内の関連部門、グローバルチームおよび関連企業と連携しながら、規制要件に基づいた情報提供・助言を行い、ビジネスの成長を薬事の観点から支えていただく重要なポジションです。
Job Description
主な業務内容|Key Responsibilities
- Lead regulatory submissions and approvals for pharmaceuticals and medical devices
- Manage communications and consultations with regulatory authorities
- Oversee updates to product labeling and packaging
- Review promotional materials to ensure regulatory compliance
- Provide regulatory insights and guidance to internal teams and global counterparts
- Build and maintain strong relationships with regulatory agencies and suppliers
- 医薬品および医療機器に関する薬事申請業務全般
- 規制当局との相談・照会対応
- 添付文書および製品包装の改訂
- プロモーション資材のレビューと適正使用の確認
- グローバルチームや社内関連部門への規制・ガイドラインに関する情報提供
- 規制当局およびサプライヤーとの良好な関係構築と維持
応募資格|Requirements
必須条件:Must Have
- Minimum 5 years of experience in Regulatory Affairs for pharmaceuticals and/or medical devices
- Fluent Japanese and business-level English proficiency
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint, Outlook)
- 医薬品および/または医療機器に関する薬事業務経験5年以上
- 日本語:ネイティブレベル、英語:ビジネスレベル
- 基本的なPCスキル(Excel、Word、PowerPoint、Outlook)
歓迎条件:Nice to Have
- Experience working in cross-functional and cross-regional teams
- Strong communication skills and adaptability in dynamic environments
- Project management experience
- クロスファンクション・クロスリージョンでの業務経験
- 高いコミュニケーション能力と柔軟な対応力
- プロジェクトマネジメント経験
このポジションの魅力|Why Join Us?
- Global Exposure: Collaborate with international teams, expanding your global perspective
- Impactful Work: Contribute to the launch and compliance of life-changing healthcare products
- Career Growth: Leverage your expertise in Regulatory Affairs to grow into leadership roles within a global organization
- グローバルな環境での業務経験:グローバルチームとの連携を通じて、国際的な視野を広げることができます。
- 医療業界の最前線で活躍:革新的な医薬品・医療機器の薬事戦略に携わり、患者さんの健康に貢献するやりがいのある仕事です。
- キャリア成長の機会:薬事の専門性を活かしながら、将来的にはリーダーシップポジションへのステップアップも可能です。
- 戦略的思考と意思決定への関与:開発初期段階から薬事戦略の策定・推進を通じて、経営層や他部門と連携しながら、重要な意思決定に関与できます。
**Additional Information*
*Relocation Assistance Provided:
No
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