Director, Regulatory Affairs

<div class="content-intro"><p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p></div><p><strong><u>ESSENTIAL JOB FUNCTIONS:</u></strong></p> <p>The Director, Regulatory Affairs will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development of Kura’s oncology and hematology portfolio. The individual must possess excellent judgment, organizational and planning skills along with exceptional written and verbal communications. &nbsp;&nbsp;</p> <p>To succeed, the candidate will have a sustained reputation for a values-driven, collaborative, engagement style where integrity and the consideration of our Patients drives decisions and actions.&nbsp;</p> <ul> <li>Contribute to the development and implementation of regulatory strategies for assigned projects.</li> <li>Lead and oversee the preparation, submission, approval, and maintenance of regulatory applications (e.g., IND/CTA, NDA/MAA, designation requests, pediatric study plans, etc.). Lead and/or assist in authoring regulatory documents and developing responses to Agency queries; manage submissions in coordination with regulatory operations.</li> <li>Lead and/or assist in the management of regulatory agency communications and interactions, preparation of briefing materials, coordination of rehearsals and minutes.</li> <li>Advise cross-functional development teams on regulatory requirements for development and approval pathways, including potential expedited pathways.</li> <li>Advise cross-functional teams and line management on regulatory risks, considerations, and strategies for program(s).</li> <li>Ensure activities and regulatory submissions are compliant with relevant laws, regulations, and guidances.</li> <li>