Senior Director, Regulatory CMC

Company Name

IDEAYA Biosciences

Job Overview

Lead the Regulatory CMC function, executing global CMC regulatory plans and overseeing submission/approval processes.

Responsibilities:

• Preparing CMC documents
• Managing cross-functional collaboration
• Ensuring alignment on regulatory strategies
• Managing CMC aspects of submissions (INDs, IMPDs, CTAs)

Requirements:

• Bachelor's degree (advanced preferred)
• 10+ years in clinical regulatory (oncology experience preferred)
• Proven leadership
• Strong track record with US/EU product approvals
• Ability to interpret ICH guidelines
• Experience reviewing CMC documentation and articulating complex regulatory issues