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Associate II, Regulatory Operations

Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: February 25, 2021

Job Description:

Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.-- Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives. Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding. Position Summary: ultrainnovative - Tackle rare and dynamic challenges 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. Requirements:
    • BA or BS degree with 2+ years of Regulatory Operations experience or an equivalent combination of education and experience preferred.
    • Must have excellent verbal and written skills, strong organizational and time management skills.
    • 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 as well as the ability to work overtime in order to meet required timelines.
    • 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. #LI-TR1 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. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact--Talent Acquisition--by calling:--(415) 483-8800--or by--emailing--us . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. 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 .

Keywords: Ultragenyx Pharmaceutical, Novato , Associate II, Regulatory Operations, Other , Novato, California

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