Director, Regulatory - CMC

Job Title: Director, Regulatory CMC

Location: San Francisco, CA (Onsite 4 days/week)

Industry: Biotechnology / Pharmaceutical

Job Summary

We are seeking an experienced Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) to join a growing biotech organization. This role will lead regulatory strategy and execution for CMC activities across development programs, with exposure to both small molecules and biologics.

The ideal candidate will bring strong expertise in global regulatory requirements and play a key role in supporting product development, submissions, and lifecycle management.

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