Associate Director, Regulatory Project Manager

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

We are looking for an Associate 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. We’ll look to you to translate global regulatory strategies into meaningful, executable submission plans, applying your project management expertise to assist us in driving our pipeline of rare disease programs into the hands of patients. You’ll be working on an exciting portfolio across broad therapeutic areas and modalities in both early and late-stage development programs as well as marketed products, with plenty of opportunities to broaden your experience and advance your career.

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 sub teams and sub team 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 5-8 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 tools 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