Associate Director, Regulatory 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.

ESSENTIAL JOB FUNCTIONS:

Reporting to the Director, Regulatory Operations, the Associate Director, Regulatory Operations is responsible for operational aspects of regulatory submissions and supports regulatory systems. This role interfaces with external publishing vendor(s) for the preparation of submissions to global health authorities, ensuring that all submissions are compliant, of the highest quality, and submitted in a timely fashion according to established timelines. The position also supports the compilation, archiving, and tracking of regulatory submissions and health authority correspondence, as well as the management and implementation of regulatory systems and tools.

• Manage Regulatory Operations to support timely & compliant submission of regulatory documents.
• Manager and perform daily operational activities for regulatory submissions (project management, resource scheduling, formatting, publishing, QC, archive and submission).
• Create and manage submission plans in conjunction with Regulatory and other cross-functional colleagues in support of timely and compliant submissions.
• Manage electronic submission publishing activities with third-party vendors and perform quality control (QC) review.
• Provide advanced editing/formatting support (document-level publishing) to ensure submission documents are accurate and meet technical formatting standards.
• Provide in-house technical expertise relating to document-level publishing (advanced editing/formatting), electronic Common Technical Document (eCTD) granularity and lifecycle management, utilization of content templates, eCTD standards and requirements.
• Track and archive submissions and health authority correspondence; manage regulatory records and databases.
• Serve as system owner for regulatory information tools and systems (e.g., eCTD publishing tools, electronic document management system (EDMS), regulatory information management Veeva (RIM) system, library system, and electronic templates)
• Maintain expert knowledge of electronic submission and computerized system validation standards.
• Ensure compliance with all applicable laws, regulations, and policies.
• Provide input into process development and refinement.
• Present project and professional information to appropriate individuals in a concise, clear, and objective manner, and with grammatical accuracy

JOB SPECIFICATIONS:

• BA degree in a science or related field.
• Ideally 8+ years in a life sciences environment, with 5+ years of relevant experience within the regulatory operations discipline.
• Knowledge of US and international regulatory requirements.
• Advanced understanding of relevant health agency eCTD requirements, formatting and submission standards, software validation concepts, and publishing best practices.
• Familiarity with dossier content requirements for global regulatory health authority submissions as well as ICH regulations and guidelines.
• Must have Veeva RIM Administrator experience
• 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.

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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 courage