Director, Regulatory - CMC

Key Responsibilities

• Lead and develop CMC regulatory strategies to support clinical development and commercialization
• Prepare and review regulatory submissions (INDs, NDAs, BLAs, amendments, and supplements)
• Ensure compliance with FDA, EMA, and global regulatory requirements
• Collaborate cross-functionally with CMC, Quality, Manufacturing, and Clinical teams
• Provide regulatory guidance on process development, manufacturing changes, and product lifecycle management
• Support interactions with regulatory agencies, including meeting preparation and responses
• Oversee preparation and review of Module 3 (CMC) documentation
• Stay current with evolving regulatory requirements and industry trends

Required Qualifications

• Bachelor's degree in Life Sciences, Chemistry, or related field (advanced degree preferred)
• 10+ years of experience in Regulatory Affairs (CMC) within biotech/pharma
• Strong experience with IND, NDA, BLA submissions
• Experience with both small molecules and/or biologics (both preferred)
• Deep understanding of global regulatory guidelines (FDA, EMA, ICH)
• Excellent communication, leadership, and stakeholder management skills