Director, Regulatory Project Management - Remote

Overview

As the Director of Regulatory Project Management at Ultragenyx, you will lead the execution of regulatory strategies within the Global Regulatory Affairs function, focusing on regulatory filing activities and project management tools to drive rare disease programs into the hands of patients.

In Short

• Lead regulatory project management initiatives for rare disease programs.
• Translate global regulatory strategies into executable submission plans.
• Manage regulatory filing subteams and operations.
• Develop and maintain regulatory timelines using project management software.
• Resolve submission execution issues with cross-functional teams.
• Track functional submission milestones and team activities.
• Identify risks and opportunities for efficiency across programs.
• Facilitate regulatory filing team meetings and communications.
• Support the development of global regulatory business processes and tools.
• Travel to Ultragenyx offices as needed.

Requirements

• Bachelor’s or higher degree in a related field with 8-10 years of experience in regulatory project management.
• Working knowledge of global regulatory agency regulations and guidelines.
• Direct experience managing marketing applications and submissions.
• Exceptional project management and organizational skills.
• Strategic thinking with a focus on regulatory strategy execution.
• Proficient in project management tools like Smartsheet and Microsoft Project.
• Experience with One Pager and Veeva Vault RIM is a plus.
• Ability to travel occasionally as needed.

Benefits

• Generous vacation time and public holidays.
• Volunteer days.
• Long-term incentive and employee stock purchase plans.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsoring.
• Professional development plans.