Director, Regulatory Project Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with Regulatory leads to oversee regulatory filing subteams and their operations, including the organization, prioritization, and monitoring of regulatory tasks related to Ultragenyx’s development and post-marketing efforts.

• Create and uphold both high-level and detailed regulatory timelines using project management software tools, incorporating insights from functional leads, cross-functional teams, and senior management, ensuring alignment of regulatory timelines with global program strategies.

• Address submission execution challenges by managing contingency plans with input from cross-functional stakeholders, resolving delays or potential delays effectively.

• Monitor functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory/submission team activities to guarantee overall compliance with timelines.

• Recognize risks and mitigation strategies, as well as opportunities for consistency and efficiency across programs within the Ultragenyx portfolio to optimally support global regulatory pathways.

• Produce and maintain program- and portfolio-level reports and dashboards to document and facilitate communications regarding regulatory milestones and submissions, ensuring all stakeholders are well-informed about activities, progress/delays, and risks/issues.

• Organize regulatory filing team and working group meetings (schedule, prepare/distribute documentation, create agendas and meeting minutes, ensure follow-up on action items; experience in meeting leadership and discussion facilitation is required).

• Assist in the development, implementation, and ongoing enhancement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management methodologies.

⛳️ Requirements

• Bachelor’s degree or higher in a relevant field with over 8-10 years of experience in regulatory project management, (bio)pharmaceutical project management, or a related discipline; PMP certification is a plus.

• Solid understanding of global regulatory agency regulations, guidelines, and submissions, including nonclinical, clinical, and CMC (bio)pharmaceutical drug/product development.

• Direct, hands-on experience managing original Marketing Applications and/or Lifecycle Management submissions from inception to submission and through to approval/post-approval.

• Outstanding project management and organizational skills, with a proven ability to prioritize and handle multiple tasks and projects to meet program and department objectives within tight timelines in a cross-functional environment that values both speed and quality.

• Demonstrated ability for strategic thinking with an emphasis on regulatory strategy execution, global process improvement, and optimization, along with a passion for developing novel project management tools.

• Highly skilled in utilizing Smartsheet, Microsoft Project, or other project scheduling tools alongside best practices for project scheduling techniques, such as managing WBS, timelines, and critical paths; direct experience with One Pager and Veeva Vault RIM is an advantage.

• Willingness to travel to Ultragenyx's offices or other locations occasionally, as required.

🏝️ Benefits

• Generous vacation time and observed public holidays.

• Volunteer days.

• Long-term incentive and Employee stock purchase plans or equivalent offerings.

• Employee wellbeing benefits.

• Fitness reimbursement.

• Tuition sponsorship.

• Professional development plans.