California Licensed CMC Regulatory Manager

Job Summary

Leading regulatory activities for IND/CTA development and maintenance, the full-time California Licensed CMC Regulatory Manager will deliver CMC regulatory support, prepare and review regulatory documents, and assess proposed CMC changes, while working in a hybrid environment that includes options for remote work.

Key responsibilities

• Deliver CMC regulatory support through QC review of submission components, ensuring compliance with regulatory requirements
• Prepare and review CMC regulatory documents and submissions to support product development and regulatory filings
• Collaborate cross-functionally on regulatory submission content and represent regulatory on study and program teams

Required qualifications

• Undergraduate degree required; advanced degree preferred
• 5+ years of experience in pharmaceutical or biotech regulatory affairs, particularly with oncology products
• Proven ability to translate regulatory requirements into practical plans
• Diverse experience with regulatory activities and document submissions to regulatory bodies
• Strong organizational skills and ability to prioritize multiple tasks in a fast-paced environment