Manager, RA CMC Group, Regulatory Affairs

📋 Description

• Execute regulatory affairs activities for assigned projects, including preparation and submission
• Collaborate with cross-functional project teams (e.g. RA TA Group, Commercial QA, Project
• Lead and implement CMC regulatory strategies, considering both global and local requirements.
• Interact with PMDA/MHLW/local authorities and internal stakeholders to facilitate communications
• 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

• Bachelor's or Master's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Public
• Experience in regulatory affairs within the pharmaceutical or healthcare industry is required
• Direct project experience (new drug development and life-cycle management) strongly preferred.
• Experience managing communications with regulatory authorities is valued.
• Solid understanding of Japan's regulatory requirements and procedures.
• Effective collaboration in multi-functional teams; openness to learning and knowledge sharing.