Director, Regulatory Project Managementremoterocketship • Remote, Oregon, United States
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Director, Regulatory Project Management
remoterocketship
- Remote, Oregon, United States
- Remote, Oregon, United States
À propos
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. 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
Compétences linguistiques
- English
Avis aux utilisateurs
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