Director, Regulatory Operations

IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery, development, and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality, which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK, Merck, Pfizer, and Gilead but wholly-owns or controls its four most-advanced clinical programs and we are committed to building a best-in-industry organization to deliver our precision medicines to the people who need them.  When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use teamwork to move science forward. For more information, please see www.ideayabio.com.
Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources.  Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio.  Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com
Position Summary:We are seeking an experienced and strategic Director of Regulatory Operations to lead and oversee global regulatory submission processes, electronic publishing, and regulatory systems management, with a particular focus on Veeva Regulatory Information Management (RIM) systems.This leadership role will drive regulatory submission excellence, process optimization, and system innovation, ensuring the timely execution of regulatory filings across multiple health authorities, including FDA, EMA, Health Canada, MHRA, and other global agencies. The ideal candidate will be a subject matter expert in Veeva RIM, with a strong background in electronic Common Technical Document (eCTD) submissions, global regulatory compliance, and document management best practices.This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

What you'll do:

• Regulatory Operations Leadership & Strategy
• Lead and strategically oversee the global regulatory submission function, ensuring compliance and operational excellence.
• Develop and execute submission strategies for INDs, NDAs, BLAs, and post-approval submissions.
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Veeva RIM System Ownership & Optimization
• Serve as the Veeva RIM subject matter expert, overseeing system implementation, maintenance, and optimization.
• Ensure Veeva RIM system integration with regulatory workflows, submission publishing tools, and document management platforms.
• Drive process automation within Veeva RIM to enhance submission tracking, metadata management, and regulatory reporting.
• Develop best practices and training programs to maximize team proficiency in Veeva RIM and regulatory technology tools.
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Regulatory Systems & Process Optimization
• Oversee regulatory submission publishing, document formatting, and electronic submission management using Veeva RIM and eCTD software.
• Ensure electronic document integrity, version control, and submission readiness within Veeva RIM and supporting platforms.
• Identify opportunities for streamlining global regulatory workflows, improving compliance, and reducing submission cycle times.
• Stay updated on emerging regulatory technology trends, ensuring the organization leverages cutting-edge digital solutions.
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Cross-Functional Collaboration & Compliance
• Partner with Regulatory Affairs, Quality, Clinical, CMC, and Com