Director, Regulatory Affairs Operations

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 a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

Reporting to the Vice President of Regulatory Affairs, the Director, Regulatory Operations is responsible for the management and oversight of regulatory submissions, systems, and associated procedures. This hands-on role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities. Additionally, the position also supports the tracking and archiving of regulatory submissions and health authority correspondence, as well as the management and implementation of regulatory systems and tools.

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, as needed. Review and contribute to the creation of standards, templates, and procedures related to regulatory documents, and recommend associated process improvements.
• Manage and mentor regulatory operations staff.
• 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.
• Minimum 10 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.
• Experience managing and mentoring direct reports.
• Must be a dedicated self-starter with the initiative and ability to take ownership of and achieve specific tasks.
• Must have strong communication, time management and organization skills.
• Must be highly detail oriented with the ability to multi-task and shift priorities quickly under tight deadlines with minimal oversight.
• Demonstrates a positive "can do" attitude and fosters collaborative internal and external relationships.

#LI-RM1

Kura’s Values that are used for candidate selection and performance assessments:

• 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

The Kura Package

• Career advancement/ development opportunities
• Competitive comp 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 variety of plans available 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 much more!

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1-mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at 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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