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

Creative Director, Brand

Key skills

About this role