規制業務スペシャリスト/ Regulatory Affairs Specialist

A multinational healthcare company is looking for a Regulatory Affairs Specialist. The selected candidate will lead regulatory activities, coordinate compliance initiatives, provide regulatory intelligence, and collaborate with internal and external stakeholders to support business operations. This is a hybrid setup role.

Responsibilities:

• Lead and supervise the Tokyo Regulatory Affairs team
• Coordinate regulatory submissions and compliance activities
• Act as a regulatory contact point for customers and authorities
• Provide regulatory intelligence for Japan
• Partner with internal business teams on regulatory impact
• Support team performance and continuous improvement
• Contribute to cross-site regulatory projects

Requirements:

• Bachelor’s degree or equivalent in Life Sciences
• Advanced experience in Regulatory Affairs
• Knowledge of Japanese regulatory requirements
• Ability to thrive in a fast-changing environment and proactively drive change across the organisation
• Native level Japanese; business level English

Preferred requirements:

• CDMO regulatory experience

About the Company:

A global leader in healthcare manufacturing and life sciences solutions, this organisation delivers innovative technologies and high-quality products that support pharmaceutical, biotechnology, and nutrition industries worldwide. Known for its strong commitment to research, operational excellence, and sustainable growth, it offers professionals the opportunity to work in a dynamic and internationally recognised environment focused on advancing healthcare and scientific innovation.

Keywords:

薬事, 規制対応, ライフサイエンス, コンプライアンス, 医薬品, 規制戦略, バイオテクノロジー, 品質保証, ヘルスケア, 求人, 外資系

Job Ref: UATU2P