[Hiring] Director, Regulatory Project Management @Ultragenyx Pharmaceutical

Role Description

We are looking for an experienced Director, Regulatory Project Manager to support the execution of regulatory strategies within the Global Regulatory Affairs function with specific focus on regulatory filing activities, project management tools and processes, and communication.

• Translate global regulatory strategies into meaningful, executable submission plans.
• Assist in driving our pipeline of rare disease programs into the hands of patients.
• Work on an exciting portfolio across broad therapeutic areas and modalities in both early and late stage development programs as well as marketed products.

Work Model: Remote - Officially documented as working full-time from home, with 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.
• Develop and maintain high level and detailed regulatory timelines utilizing project management software tools.
• Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input.
• Track functional submission milestones and regulatory/submission team activities.
• Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs.
• Develop and maintain program- and portfolio-level reports and dashboards for regulatory milestone and submission communications.
• Facilitate regulatory filing team and working group meetings.
• Support the development, implementation, and continuous improvement of global regulatory business processes.

Qualifications

• 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.
• 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.
• Demonstrated capacity for strategic thinking with a focus on regulatory strategy execution.
• Highly proficient with using Smartsheet, Microsoft Project, or other project scheduling tools.

Requirements

• Travel to Ultragenyx's offices or other locations on occasion, as needed.

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.
• Benefits vary by region and country.