RA TA Group, Regulatory Affairs

📋 Description

• Execute regulatory affairs activities for assigned projects, including preparation and submission
• Collaborate with cross-functional project teams (e.g., Clinical Development, Project Management
• Lead and implement regulatory strategies, considering both global and local requirements.
• Interact with PMDA/MHLW and internal stakeholders to facilitate communications, resolve issues, and
• Monitor and interpret regulatory changes/practices relevant to assigned products/areas; communicate
• Support the development and maintenance of regulatory SOPs and best practices, if applicable.

🎯 Requirements

• Manager, Regulatory Affairs (RA) Therapeutic Area (TA) Group, Regulatory Affairs Japan, is
• Proactively collaborates with internal and external stakeholders and contributes to continuous
• Experience with regulatory affairs, including preparation and submission of documents to PMDA/MHLW.
• Ability to collaborate with cross-functional teams and lead regulatory strategies.

🎁 Benefits

• Individual development opportunities and chance to utilize our internal learning platform with a
• Opportunity to be part of a collaborative global working environment with support from passionate