Associate II, Regulatory Affairs Operations
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
Ultragenyx is seeking a highly motivated individual for the role of Associate II, 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 Associate will publish moderately 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.
Responsibilities, including but not limited to:
- Performs routine general formatting, template adherence, ToC generation, version control and routine document processing activities associated with the preparation of submission-standard regulatory documents for both hard copy and electronic submissions
- Participates in the electronic compilation and publishing of routine documents and reports using InSight Publisher and associated publishing tools
- Be able to identify basic issues and proactively engage appropriate individuals for a resolution
- Utilizes systems and tools for electronic document capture, generation, manipulation, scanning 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 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 provide training to functional group contributors on regulatory document content and format
- 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 in the correct format
- Exercises judgment within well-defined procedures and practices to determine appropriate action
- ABA or BS degree with 2+ years of Regulatory Operations experience or an equivalent combination of education and experience preferred
- Must have a strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
- Experience in managing shifts in/competing priorities or unforeseen challenges, without compromising quality, attention to detail and timeline deliverables while successfully communicating and working with supervisor and team members
- Must be able to master new technical skills and apply them to projects as the industry, and the company, evolves
- Should demonstrate flexibility and willingness to accommodate ad-hoc requests and work effectively within an environment that has quickly changing processes, priorities and deadlines
- Must have a good working knowledge and understanding of MS Word, Word templates, Adobe Acrobat, ISIToolbox, eCTD validation software, InSight Publisher and standard Office tools
- Works under limited direction and may independently determine and develop approaches to non-routine problems
- A good understanding of regulatory procedures, filing requirements and publishing is required
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.