Director, Regulatory Affairs CMC

Responsibilities

• Develop and execute CMC regulatory strategies for clinical and commercial development
• Manage preparation of high-quality CMC regulatory submissions including IND, IMPD, BLA, MAA and post-approval supplements
• Represent Regulatory CMC in project teams and provide strategic input
• Plan Health Authority meeting requests, briefing books and responses to information requests
• Review CMC sections of submissions for regulatory compliance
• Lead regulatory interactions with Health Authorities
• Develop CMC regulatory strategies and risk assessments for assigned projects
• Support Health Authority inspections and interpretation of global CMC regulations

Requirements

• Bachelor's degree in chemistry, pharmacy, engineering, biochemistry or related science
• 10+ years Regulatory CMC or pharmaceutical industry experience
• Experience in biologics
• Thorough knowledge of FDA, EU and global regulations
• Experience developing regulatory strategy for complex products
• Experience engaging with health authorities on CMC topics
• Clear written and oral communication skills

Preferred Qualifications

• Master's degree or advanced degree
• Proficiency in Mandarin Chinese (spoken and written)
• Experience with electronic document management systems

About the Company

• Biopharmaceutical oncology company developing ivonescimab in multiple global Phase 3 studies.