Remote Director, Regulatory Project Management

Summary

Join Ultragenyx, a biopharmaceutical company focused on rare disease treatments, as a Director, Regulatory Project Manager. You will play a crucial role in managing regulatory filings, developing timelines, and ensuring compliance. This position requires extensive experience in regulatory project management within the pharmaceutical industry and strong project management skills. The role offers a flexible work model (Flex or Remote) and a competitive salary and benefits package, including annual bonuses, equity incentives, generous vacation time, and professional development opportunities. Ultragenyx fosters a supportive and inclusive work environment, committed to both patient care and employee well-being. The ideal candidate will be a strategic thinker with a passion for process improvement and a proven track record of success in managing complex regulatory submissions.

Requirements

• Bachelor’s or higher degree in a related field with >8-10 years of experience in regulatory project management, (bio)pharmaceutical project management, and/or related discipline; PMP certification a plus
• Working knowledge of global regulatory agency regulations, guidelines, and submissions and nonclinical, clinical, and CMC (bio)pharmaceutical drug / product development
• Direct hands-on experience managing original Marketing Applications and/or LCM submissions from creation to submission through approval / post-approval
• Exceptional project management and organizational skills are required, with demonstrated ability to prioritize and manage multiple tasks and projects to achieve program and department goals under tight timelines in a cross-functional environment that values both speed and quality
• Demonstrated capacity for strategic thinking with a focus on regulatory strategy execution and global process improvement and optimization and passion for novel project management tool building
• Highly proficient with using Smartsheet, Microsoft Project, or other project scheduling tool(s) in conjunction with best practices for project scheduling techniques such as managing WBS, timelines, and critical path; direct experience with OnePager and Veeva Vault RIM is a plus
• Travel to Ultragenyx's offices or other locations on occasion, as needed

Responsibilities

• Partner with Regulatory leads to manage regulatory filing subteams and subteam operations, including the coordination, prioritization, and tracking of regulatory activities associated with Ultragenyx’s development and post-marketing activities
• Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies
• Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
• Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines
• Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs in the Ultragenyx portfolio to most effectively support global regulatory pathways
• Develop and maintain program- and portfolio-level reports and dashboards to document and facilitate regulatory milestone and submission communications and ensure that all stakeholders are informed and knowledgeable of activities, progress / delays, and risks / issues
• Facilitate regulatory filing team and working group meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required)
• Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices

Preferred Qualifications

• PMP certification
• Direct experience with OnePager and Veeva Vault RIM

Benefits

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans
• Annual bonus
• Equity incentives
• Flex work model (2-3 days onsite)
• Remote work option