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.
ultrafocused – Work together to fearlessly uncover new possibilities
Ultragenyx is seeking a highly motivated individual for the role of Senior Associate, Regulatory Operations in the Regulatory Affairs Department. As a member of the Regulatory Operations team, this position electronically prepares documentation that is complete, accurate, on time, and electronically functional. The candidate will publish moderately complex to complex, non-routine reports such as technical, nonclinical, and clinical reports and assist with submissions, including INDs, eCTDs, NDAs, BLAs, supplements and amendments under limited supervision. Responsibilities also include archiving regulatory submissions in accordance with company standards.
Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
Or
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
- Performs moderately complex to non-routine submission publishing activities associated with generating electronic submission-ready documents and aggregated reports.
- Prepares a variety of moderately complex submissions using publishing applications and associated publishing tools in accordance with company and industry regulations.
- Utilizes systems and tools for electronic document capture, generation, and QC.
- Ensures final document components are electronically archived according to the departmental practices.
- May represent Regulatory Operations by taking the lead in submission planning and report level process meetings.
- Participates in the development or upgrading of templates as well as guidance.
- Participates in supporting and promoting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
- May interface with cross-functional teams and or content authors to discuss routine submission preparation and content.
- May assist and/or provide training to others on software tools used and educating authors on publishing policies and procedures.
- Identifies and records issues that require resolution prior to finalization and liaises with responsible author to resolve issues. Assists authors in the completion and compilation of regulatory documents to ensure all components are provided and presented and meet electronic submission requirements.
- Exercises judgment within well-defined procedures and practices to determine appropriate action.
- BA or BS degree with 5+ years of Regulatory Operations experience or an equivalent combination of education and experience preferred.
- Experience in successfully working in a fast-paced environment with tight timelines, large deliverables.
- Strong understanding of regulations related to electronic records and electronic signature (21 CFR Part 11)
- Must be able to master new technical skills and apply them to projects as the industry, and the company, evolves.
- Must demonstrate flexibility and willingness to accommodate ad-hoc requests and work effectively within an environment that has quickly changing processes, priorities and deadlines as well as to work overtime in order to meet required timelines.
- Must have a strong working knowledge and understanding of MS Office tools with advanced skills specifically in MS Word and templates, Adobe Acrobat Pro, ISI ToolBox, eCTD validation software, Veeva Vault RIM for Submissions and DocuBridge Publisher.
- Works well under general direction and may independently determine and develop approaches to non-routine problems.
- An excellent understanding of regulatory procedures, filing requirements and publishing is required. #LI-CS1 #LI-Hybrid #LI-Remote
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
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Employee wellbeing benefits
- 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.
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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.