Senior Manager - Associate Director, Regulatory Affairs, Japan

BeOne is seeking a Senior Manager - Associate Director, Regulatory Affairs, Japan to develop, implement, and advise on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives.

Requirements

• Minimum 10 years of experience in the biotechnical or pharmaceutical industry
• Minimum 5 years of experience in a Regulatory capacity with a broad background
• Minimum 5 years of experience working on development programs running in Japan as a Japan regulatory lead
• Extensive regulatory experience with CTNs, NDAs/BLAs/MAAs, lifecycle management, interactions with Japan Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies
• Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends

Benefits

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• In-house and external learning and development opportunities
• Fantastic benefits program