Why Join Us?
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!
We are located in Novato, CA, 25 miles north of San Francisco with additional office space coming soon in Brisbane, CA.
The Senior Associate, Regulatory Affairs will be responsible for providing support for all regulatory aspects (nonclinical, clinical, CMC) of product development. The responsibilities include coordination, preparation and submission of a variety of regulatory submissions and working closely with functional areas and project teams. The individual must possess basic knowledge of rules, regulations, and guidances governing drugs and biologics in all phases of development. Excellent verbal and written communication skills are required. The position level is dependent upon experience and qualifications.
• Assist with the development and/or review of regulatory documents to ensure that all health authority submissions are of high quality.
• Assist with creating and maintaining regulatory timelines and tracking deliverables to ensure regulatory submission timelines are met.
• Interface with functional areas (CMC, Nonclinical, Clinical, Commercial) to identify and obtain information required for regulatory submissions.
• Provide critical review of documents (SOPs, protocols, and reports) related to clinical, nonclinical or manufacturing, as necessary.
• Assist with preparing/coordinating/filing/managing regulatory applications (INDs/CTAs, NDAs/BLAs/MAAs), annual reports, and information amendments in multiple countries for multiple protocols.
• Assist with development strategy and regulatory team preparation for project team and subteam meetings.
• BA/BS degree in a science field required; Regulatory Science program or RAC preferred.
• 2+ years of experience in Regulatory Affairs in the Pharmaceutical industry.
• Excellent attention to detail with solid coordinating, task planning and time management skills.
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.