Associate Director, Regulatory Affairs CMC Japan

Ultragenyx is seeking an Associate Director of Regulatory Affairs CMC for its Japan office. The role will lead and execute related chemistry, manufacturing, and controls (CMC) regulatory activities/interactions. The Associate Director will develop regional regulatory CMC strategies for established and development products, serving as a key operational interface with global and regional teams.

Requirements

• BA/BS in a scientific field of study
• 8+ years of relevant experience working in Regulatory in the pharmaceutical/biotech industry
• Strong knowledge, experience, and ability to provide technical guidance in interpretation of regulations and guidelines related to biological drugs and regenerative medicinal products development
• Proven ability to analyze and organize information logically
• Sound understanding and practical application of industry standards and international regulations and guidelines
• Experience in clearly and effectively communicating regulatory strategies, submission documents, and plans both internally and externally
• Ability to effectively coordinate, manage, and prioritize multiple projects in a fast-paced, deadline-driven start-up environment
• Strong collaboration, teamwork, organizational skills at attention to detail
• Excellent written and verbal English and Japanese communication skills

Benefits

• Generous vacation time
• Volunteer days
• Long term incentive and Employee stock purchase plans
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans