激動の医薬品業界で
将来を見据えたキャリアを築く。

仕事内容の欄にまとめて記載

Primary Purpose:
Provides Japanese Labelling & Artwork Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross functional teams.

Responsibility:

• 新薬申請及び市販製品の変更管理におけるCMC薬事戦略を構築するとともに、レギュラトリーリスクを時宜特定し、対応策を立案する。

• 高品質のCMC承認申請資料を作成する。

• 規制当局からの照会事項に対してタイムリーな回答作成を行う。

• 新薬申請及び市販製品の変更管理においてタイムリーに承認を取得する。

• 最新のCMC薬事情報の把握と規制当局及び業界への高い影響力を持つ。

Basic purpose of the job
•Control the CapEx project which is a large, complex and strategic investment in Japan
throughout all project phases (feasibility study, basic design, technical planning, execution,
commissioning, qualification / validation and documented handover to users) 
•The control tasks consist of monitoring project schedule, cost and resources and managing risks,
action items, other PMO tasks and reporting the project status to Project Managers.
•Support Project Managers in order to implement projects smoothly e.g. solving issues,
communication / negotiation with stakeholders and provide PM documents such as BI CapEx application.
•Managing external companies e.g. outsourced PM services such as meeting arrangement,
document control, review of PM documents.

The Production Department at our Koriyama Factory in Fukushima is at the forefront of innovation and efficiency. With a focus on delivering high-quality products to our customers, the team is in-charge of optimising every step of the production process, from inventory planning to regulatory compliance. The department fosters a collaborative and dynamic atmosphere, where your contributions will directly impact our mission to improve lives. Located in the beautiful Fukushima region, the Koriyama Factory is a hub of innovation and excellence, supported by a pasionate team of professionals.