Overview Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be part of something bigger, with a lasting impact you can be proud of. We are changing the paradigm and improving the science of cancer treatment with a diverse and talented professional culture focused on developing precision medicine therapeutics. To succeed at Kura, you will demonstrate excellence in drug discovery and development with a roll-up-your-sleeves attitude, and uphold values-driven work where integrity and grit drive all decisions and actions.

Please make sure you read the following details carefully before making any applications. Reporting to the Vice President of Regulatory Affairs, the Associate Director, Regulatory Operations is a hands-on role responsible for the management and oversight of regulatory submissions, systems, and associated procedures. This role interfaces with external publishing vendors for the preparation of submissions and with internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities. The position also supports tracking and archiving regulatory submissions and health authority correspondence, and manages and implements regulatory systems and tools. This role is critical to building and continuously improving processes to make regulatory operations best-in-class. Essential Job Functions Direct all regulatory submissions management activities, including submission content and timeline planning and coordination of dossier compilation and QC review to ensure submission quality and compliance for health authority acceptance. Act as submission manager for applications and represent Regulatory Operations on relevant project teams, as needed. Ensure document management tasks are completed in a compliant manner including creation, tracking, storage, and archival of regulatory submissions, correspondence, and other documentation. Manage regulatory records, logs, and databases. Key contact for all enterprise systems-related timelines and projects for regulatory information and document management. Serve as business system/process owner, as needed. Oversee the implementation and operation of software and business processes for electronic document and regulatory information management systems (e.g., Veeva RIM), eCTD templates, eCTD publishing tools, and other products as needed (e.g., Veeva PromoMats). Lead the development and implementation of internal procedures, work instructions, and training programs for document and dossier management, archiving, and other processes. Review and contribute to the creation of standards, templates, and procedures related to regulatory documents, and recommend associated process improvements. Take ownership of building and improving standards, templates, and workflows to create scalable, repeatable processes. Responsible for vendor management, building relationships with business partners and managing budgets and contracts. Provide subject matter expert level strategic insight on regulatory technologies and processes related to registration documents, submission records and associated product data records. Monitor and assess business trends, pending regulations and/or guidance documents for potential regulatory operations impact. Other duties as assigned. Job Requirements BA/BS degree in a science or related field, or equivalent combination of education, experience, and training. 8+ years regulatory operations experience in a biotechnology or pharmaceutical environment with demonstrated ability to present and articulate requirements. Advanced knowledge of regulatory submission requirements, guidelines, and publishing standards, including computer word processing, electronic document management systems, and publishing software. Extensive eCTD filing experience with IND/CTA and NDA stages, including labeling and post-approval promotional materials. Experience managing an outsourced regulatory publishing model is a plus. Experience managing medium to large scale systems (e.g., RIM, EDMS). Experience with Veeva RIM and PromoMats, a plus. Demonstrated ability to facilitate, lead and manage the establishment of procedures. Must be highly detail oriented with the ability to multi-task and shift priorities quickly under tight deadlines with minimal oversight. Drives work independently with ownership and accountability; delivers consistent, high-quality results with minimal oversight. Thrives in a fast-paced, dynamic environment and adapts quickly to shifting priorities. Builds scalable processes and finds better ways of working, always looking to improve efficiency and quality. Strong communicator and collaborator; works effectively across teams and with vendors to keep projects moving. Detail-oriented and organized, with the ability to manage multiple priorities and meet deadlines. Kura Values and Benefits We work as one for patients We are goal-focused and deliver with excellence We are science-driven courageous innovators We strive to bring out the best in each other and ourselves Career advancement/ development opportunities Competitive compensation package Bonus 401K + Employer contributions Generous stock options ESPP Plan 20 days of PTO to start 18 holidays (including Summer & Winter Break) Generous Benefits Package with a substantial employer match Paid Paternity/Maternity Leave In-Office Catered lunches Home Office Setup Lifestyle Spending Stipend Commuter Stipend (Boston Office) Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and more Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for cancer. Our pipeline includes small molecule candidates targeting cancer signaling pathways. Ziftomenib is the first and only investigational therapy to receive Breakthrough Therapy Designation from the FDA for relapsed/refractory NPM1-mutant AML. In November 2024, Kura Oncology entered a global strategic collaboration with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 trial has been completed, and the FDA accepted a New Drug Application with a target action date of November 30, 2025. KO-2806 and Tipifarnib are in various stages of development. For more information, visit www.kuraoncology.com and follow us on X and LinkedIn. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. 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