Regulatory Affairs Manager

Regulatory Affairs Manager role at a global pharmaceutical company, responsible for developing and executing regulatory strategies in Korea, ensuring compliance and providing strategic input to R&D projects.

Requirements

• Bachelor degree or above in life science, engineering or mechanical discipline
• Minimum 8-10 years regulatory affairs experience in MNCs
• Regulatory knowledge of Japan and other APAC countries is a plus
• In-depth understanding of Korea regulatory framework and registration requirement
• Solid hands-on submission experience and strong technical skills associated with active medical devices
• Fluency in written and spoken English