Senior Director, Regulatory CMC

Company Name: IDEAYA Biosciences

Job Overview

IDEAYA Biosciences seeks a Senior Director, Regulatory CMC to lead the Regulatory CMC function. This role involves planning and executing CMC regulatory strategies for therapeutic development programs, defining strategy with stakeholders, and managing processes.

Responsibilities

• Overseeing CMC regulatory submissions (INDs, Marketing Authorization Dossiers)
• Ensuring global approvals
• Interpreting regulatory guidelines
• Collaborating cross-functionally

Requirements

• Bachelor's degree in Life Sciences (advanced degree preferred)
• At least 10 years of clinical regulatory experience, preferably in oncology
• Strong leadership skills
• Excellent communication skills
• Strategic thinking skills