Senior Director, Regulatory CMC

Job Summary

Leading regulatory CMC strategies for biologics, the full-time Senior Director, Regulatory CMC will develop and execute global regulatory submissions while collaborating with cross-functional teams in a remote environment.

Key responsibilities

• Develop CMC regulatory strategies for biologics across all development stages and ensure compliance with global regulations
• Provide strategic and operational regulatory direction on CMC issues and lead regulatory submissions, including INDs and BLAs
• Serve as the regulatory CMC subject matter expert in interactions with health authorities and manage relationships with external partners

Required qualifications

• Bachelor's degree in chemistry, pharmacy, engineering, biochemistry, or related science; advanced degree preferred
• 15+ years of regulatory CMC experience in the pharmaceutical industry, with a focus on biologics
• Thorough knowledge of FDA, EU, and global regulations related to CMC
• Significant experience in developing regulatory strategies and preparing CMC sections for complex submissions
• Proficiency in Mandarin Chinese (spoken and written) is highly desirable