Senior Director, Regulatory CMC

Role Summary

Senior Director, Regulatory CMC at IDEAYA Biosciences. Lead the Regulatory CMC function, planning and executing CMC regulatory strategies for IDEAYA’s therapeutic programs, ensuring first-pass global approvals of CMC submissions. Reports to the Vice President of Regulatory Affairs. Onsite four days per week in South San Francisco.

Responsibilities

• Lead the Regulatory CMC function to support development projects and CMC portfolio goals.
• Execute global CMC regulatory plans; oversee submission and approval processes in collaboration with CMC and Regulatory Affairs.
• Prepare CMC documents in response to Health Authority requests.
• Collaborate cross-functionally to generate CMC regulatory documents, review, and resolve comments.
• Be a member of program-specific regulatory teams.
• Partner with Technical Operations, Manufacturing, and Quality to align regulatory plans and priorities.
• Manage CMC aspects of eCTD submissions for INDs/IMPDs/CTAs, annual reports, and marketing applications.
• Interpret and implement ICH guidelines to achieve harmonized regulatory control strategies.
• Develop, review, and comment on technically complex CMC documentation (process development, validation, comparability, analytical methods, specifications, stability).
• Identify risks and propose innovative regulatory and technical solutions; communicate probabilities of success.
• Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization.

Qualifications

• Bachelor’s degree in Life Sciences or equivalent; advanced degree (MS/PhD/PharmD) preferred.
• Minimum of 10 years in clinical regulatory with leadership potential; oncology experience preferred.
• Proven ability to develop and manage a high-performance regulatory CMC team.
• Strong track record for oncology product approvals in the US and EU preferred.
• Thorough understanding of drug development, regulatory requirements, guidance, and policy trends.
• Knowledge of eCTD elements, structure, and Module 3; hands-on experience with CMC submissions (INDs, IMPDs, NDAs, MAAs).
• Experience with global Health Authority interactions, including FDA CMC development meetings.
• Experience collaborating with CDMOs and partners is a plus.
• Strategic thinking with strong analytical and execution abilities; global regulatory submission experience preferred.

Skills

• Outstanding interpersonal and cross-functional collaboration skills.
• Excellence in regulatory liaison/strategy and negotiations with authorities.
• Strategic leadership, project management, and strong technical background.
• Ability to analyze global regulatory requirements and synthesize global development strategies.
• Excellent written and verbal communication; ability to prepare complex submissions and presentations.
• Ability to work independently.

Education

• Bachelor’s degree in Life Sciences or equivalent; advanced degree preferred.

Additional Requirements

• Onsite in South San Francisco four days per week; no remote option stated beyond policy.