Associate II, Regulatory Operations
Company: Ultragenyx Pharmaceutical
Posted on: February 25, 2021
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
- 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
- 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
- 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
firstname.lastname@example.org . 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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