🛠 Tech Stack

💼 About This Role

You'll lead regulatory filing activities and project management for rare disease programs at Ultragenyx Pharmaceutical. You'll translate global regulatory strategies into executable submission plans, driving pipeline programs to patients. This remote role offers opportunities across diverse therapeutic areas.

🎯 What You'll Do

• Partner with regulatory leads to manage filing subteams and track activities
• Develop and maintain regulatory timelines using project management tools
• Resolve submission issues and manage contingency plans with stakeholders
• Track milestones and develop program-level reports and dashboards
• Facilitate filing team meetings and ensure action item follow-up

📋 Requirements

• Bachelor's degree and 8-10 years of regulatory project management experience
• Working knowledge of global regulatory agency regulations and submissions
• Direct hands-on experience managing original Marketing Applications from creation to approval
• Exceptional project management and organizational skills with ability to prioritize

✨ Nice to Have

• PMP certification
• Experience with Smartsheet, Microsoft Project, or similar scheduling tools
• Knowledge of One Pager and Veeva Vault RIM

🎁 Benefits & Perks

• 💰 Annual bonus and equity incentives
• 🗺️ Remote work from home with occasional travel
• 📈 Career growth opportunities across therapeutic areas

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Panel Interview· 60 min