Senior Associate, Regulatory 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 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 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 moderately complex to non-routine submission formatting activities associated with generating hard copy and electronic submission ready documents and reports
- Prepares a variety of moderately complex submissions using InSight Publisher and associated publishing tools
- 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 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 in the correct format
- 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.
- Ability to manage multiple ongoing projects simultaneously.
- Must have a very strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents
- Ability to follow complex direction/processes under pressure
- Ability to solve complex problems under time pressures
- 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 as well as the ability to work overtime in order to meet required timelines
- Must have a strong working knowledge and understanding of MS Word, Word templates, Adobe Acrobat, ISIToolBox, eCTD validation software, InSight Publisher and standard Office tools
- 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
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.
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: firstname.lastname@example.org.