Reporting to the Head 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.

The base range for a Director is $216,090 - $238,309 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.