Senior Manager, Regulatory Information Management at Ultragenyx in

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultraimpact – 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. This role will be responsible for regulatory data and document management which includes data entry, archiving, data quality monitoring, reporting, analytics and associated RIM processes. The incumbent will have a general working knowledge of Regulatory Affairs, Health Authority submissions and archives.

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:

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.

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.
Occasional travel may be required. #LI-CS1 #LI-Remote

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$148,700—$183,600 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · 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

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.