Director, Regulatory Project Management

Role Overview

• 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

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 One Pager and Veeva Vault RIM is a plus
• Travel to Ultragenyx's offices or other locations on occasion, as needed.

Tech Stack

• PMP
• Vault

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