Associate II, Regulatory Operations
Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: February 25, 2021
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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:
Keywords: Ultragenyx Pharmaceutical, Novato , Associate II, Regulatory Operations, Other , Novato, California
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