Senior Director, Regulatory CMC

Role Summary

IDEAYA Biosciences is seeking an experienced, motivated leader to head Regulatory CMC. The Senior Director, Regulatory Affairs CMC will plan and execute the CMC regulatory strategies for IDEAYA’s therapeutic development programs, define the CMC regulatory strategy in partnership with key stakeholders, and manage processes required to plan and execute CMC regulatory plans. This role will lead Module 3 (Quality) of INDs and Marketing Authorization Dossiers, provide product-level leadership to achieve first-pass global approvals of CMC submissions, and interpret and implement current CMC regulatory guidelines to support approvability in high-priority regions. The position reports to the Vice President of Regulatory Affairs and is based in South San Francisco, onsite four days per week.

Responsibilities

• Lead the Regulatory CMC function to support development projects and portfolio goals.
• Execute global CMC regulatory plans, overseeing submission and approval processes in partnership with CMC and Regulatory Affairs.
• Prepare CMC documents in response to Health Authority requests for information.
• Collaborate cross-functionally to generate CMC regulatory documents, review comments, and drive resolution.
• Be a member of program-specific regulatory teams.
• Partner with Technical Operations, Manufacturing, and Quality to align on regulatory plans and priorities.
• Manage CMC aspects of eCTD submissions (IND/IMPD/CTA), annual reports, and marketing applications.
• Interpret and implement ICH guidelines to achieve harmonized regulatory strategies.
• Develop, review, and comment on technically complex CMC documentation, including process development/validation, comparability studies, analytical method development/validation, and specifications related to development phase.
• Anticipate risks and lead discussions to identify innovative solutions, communicating probabilities of technical and regulatory success.
• Articulate complex CMC regulatory issues to project teams and external stakeholders to support global development and commercialization.

Qualifications

• Bachelor’s degree in a Life Sciences discipline or equivalent; advanced degree (MS/PhD/PharmD) preferred.
• Minimum of ten years of experience 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 and regulatory landscape, including eCTD requirements and Module 3 expertise.
• Hands-on experience with CMC submissions (INDs, IMPDs, NDAs, and/or MAAs).
• Experience with global Health Authority interactions, including FDA CMC development meetings.
• Experience collaborating with CDMOs, contractors, and partners is a plus.
• Strategic thinking with strong analytical and execution skills; ability to work on international regulatory submissions.

Skills

• Outstanding interpersonal and cross-functional collaboration skills
• Strong regulatory liaison/strategy and negotiation abilities with authorities
• Leadership, strategic thinking, and project management capabilities
• Ability to synthesize worldwide regulatory requirements into global development strategies
• Excellent written and verbal communication for complex submissions and presentations
• Independent work capability

Education

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

Additional Requirements

• Onsite work four days per week at the South San Francisco headquarters