Japan_Development pharmaceutical affairs

Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.

Celltrion Group offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands-on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets around the world, Celltrion Group has been securing distribution channels and providing patients with biosimilars at affordable prices.

In charge of the following tasks, mainly regulatory affairs and quality assurance work corresponding to the product life cycle of biopharmaceuticals.

Regulatory affairs and quality assurance work centered on application work for individual projects within the department.

• Pharmaceutical applications for drugs, work dealing with authorities (applications and change notifications)
• Creation and review of CTD and FD application documents, etc., and associated internal and external coordination and communication, etc.
• Participation in new product introduction projects from the regulatory and quality assurance aspects
• Regulatory consultation work
• CMC regulatory support
• Negotiate and coordinate with manufacturers, etc. to ensure there is no discrepancy between the approved content and manufacturing methods.

バイオ医薬品の製品ライフサイクルに対応した薬事及び品質保証業務をご担当頂きます。

申請業務を中心とした薬事及び品質保証業務。

部署内で個々のプロジェクトに応じて担当していただくことになります。

• 医薬品の薬事申請、当局対応業務（申請・変更届）
• CTD及びFD申請書類等の作成・確認およびそれに伴う社内外との調整、コミュニケーション等
• 新製品導入プロジェクトの薬事・品質保証方面からの参画
• 当局薬事相談業務
• CMC薬事支援
• 製造業者等との交渉及び調整を行い、承認内容と製造方法に齟齬がないように維持。

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