Remote Senior Manager, Regulatory Information Management
at Ultragenyx

Summary

Join our team at Ultragenyx to make a difference for those who need it most. We are seeking a skilled and detail-oriented Sr. Manager to join our Regulatory Information Management (RIM) team.

Requirements

• Experience with document management and regulatory information tracking supporting Regulatory Affairs submissions and related activities
• Veeva Vault RIM Submissions, Submissions Archive and Registrations experience required
• Experience providing user support and training of Regulatory Systems supporting Regulatory Information Management
• Detail-oriented with the ability to organize, prioritize, and execute required tasks to meet timelines
• Ability to work independently and use critical thinking to perform tasks with appropriate escalation to manager
• Highly collaborative team player with excellent communication and interpersonal skills enabling development of positive relationships
• Understanding and hands-on experience with related technologies supporting the global Regulatory business (e.g., SharePoint, Smartsheet, etc.)
• Proficient in the use of Microsoft Office Suite (Word, Excel, Power Point, Project, Visio)
• Bachelor's degree (within a life sciences subject or information technology) with 7+ yrs experience in Regulatory, Regulatory Information Management, Regulatory technology or equivalent

Responsibilities

• Drives and performs process for regulatory data and document management activities including data entry and archiving
• Develops and executes Regulatory Information data quality procedures including data monitoring, quality metrics and data remediation
• Manages data quality issues in Regulatory Systems (e.g., Veeva Vault RIM) and supports escalations/resolutions
• Supports Regulatory System enhancements which includes input to requirements and proposed solutions, testing and impacted business process updates
• Supports the development and update of controlled process documentation and training material associated with RIM and Regulatory systems
• Provides real-time support for RIM activities as requested by end users and delivers training support as needed
• Supports reporting and dashboarding of Regulatory Information as needed to meet business requirements
• Supports the development and maintenance of Regulatory Information Data standards
• Promotes a culture of collaboration, quality, operational excellence, and continuous improvement, supporting company growth

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