Director, Global Regulatory Information Systems
Company: Ultragenyx Pharmaceutical
Posted on: May 3, 2021
Director, Global Regulatory Information Systems
At Ultragenyx, we fundamentally believe that taking real
impactful action to care for the needs of patients and our people
is always the right thing to do.To achieve this goal, our vision is
to lead the future of rare disease medicine. For us, this means
going where other biopharma companies wont go challenging the
status quo and creating a new model that advances our field so more
patients and caregivers can benefit from life-changing treatments.
We do this by following the science, applying a novel rapid
development approach, making innovative medicines at fair and
reasonable prices, and creating a collaborative ecosystem to reach
patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so
culture is an essential cornerstone for Ultragenyx. We remain
continuously focused on creating a supportive and inclusive
environment of profound learning and growth so employees can thrive
in all areas of their lives, in and outside of work. Ultimately, we
want to be an organization where we would be proud for our family,
friends and children to work.
If you want to have a meaningful impact, do the best work of
your career, and grow a lot, both professionally and personally,
come join our team. 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 ourapproachwill includevideo discussions, interviews,
The Director of Global Regulatory Information Systems leads the
regulatory information management (RIM) program for Ultragenyx
globally (Ultragenyx Pharmaceutical (UGX) and Ultragenyx Gene
Therapy (UGT)). This individual is a strategist, collaborator, and
confident leader that understands the complexities of RIM and is
passionate about driving and delivering meaningful changes to
support our current and future RIM goals.
The position requires a solid understanding of Regulatory
Affairs/Operations and extensive hands-on expertise in Regulatory
specific technology (e.g. InSight Publisher/Viewer and Veeva Vault
RIM), excellent business analysis and project management
This individual collaborates with Global Regulatory Affairs
(UGX/UGT) and other cross-company functions in driving the
development and refinement of our existing and desired global
processes to support a robust RIM program to take Ultragenyx into
This individual will report to the Executive Director,
Regulatory Operations. This role requires outstanding
interpersonal, communication, leadership and collaboration skills
along with the ability to synthesize information and translate it
into meaningful strategy.
- Translate global RIM-related regulations into meaningful
business requirements and solid action plans to support current and
future RIM initiatives over the next 3-5 years.
- Provides leadership and subject matter expertise on Regulatory
- Responsible for the execution and delivery of Regulatory
systems projects (new implementations, mergers, upgrades, and
- Responsible for the daily business administration of Regulatory
systems (e.g. SharePoint, InSight Publisher/Viewer and Veeva Vault
RIM), including (but not limited to) user management, training,
issue escalation and resolution and working with IT and third-party
- Drive the development and/or refinement of business process
maps by working cross-functionally to identify future state process
requirements and documentation to support the desired future
- Responsible for driving the documentation and revision of all
Regulatory Affairs systems SOPs, and work instructions (WIs) for
- Drive the development and updates for training presentations
and other relevant training material for Regulatory systems.
- Works collaboratively with IT business partners in the
management of enterprise systems, the development and adherence to
- Maintain a robust data foundation across Global Regulatory
Affairs/Operations processes and systems in order to make
information accessible and connected to support regulatory business
- Partner with vendors and/or IT business partners in keeping
abreast of technology trends and applicability to business
- Collaborates on technology initiatives and applies leadership
skills by working in a global environment with business colleagues
across functional teams including (but not limited to) Clinical,
BioStats, DSPV, and CMC.
- Promote a culture of quality, operational excellence and
continuous improvement, supporting company growth.
- May manage/mentor direct reports and contractors.
- Excellent technical understanding and proven, hands-on
experience in technologies such as SharePoint, eCTD Publishing
Tools (InSight Publisher/Viewer), Veeva Vault RIM, and
off-the-shelf and plug-in software such and StartingPoint
Templates, DXC Toolbox that supports the global Regulatory business
and have solid understanding in developing Regulatory requirements,
such as IDMP.
- Highly collaborative team player that can communicate clearly
to both technical and non-technical stakeholders to understand
challenges and drive for win-win outcomes.
- Exceptional problem solving skills and ability to formulate
innovative solutions that demonstrate both strategic and tactical
- Demonstrated ability to organize, prioritize, and execute on
projects to completion.
- Proven experience in leading organizational change and
- Strong knowledge of control and management of
regulatory-focused content, throughout the product lifecycle
stages, SDLC methodologies and CFR Part 11 and Annex 11
- Proven experience in staff management, coaching and career
- Excellent judgment and interpersonal skills, consensus and
- Outstanding presentation skills and professional presence.
- Veeva Vault Platform Administrator certification, highly
- Bachelor's degree (within a life sciences subject or
information technology) with 8+ yrs experience in Regulatory or
Regulatory technology or equivalent with extensive knowledge of
global regulatory industry initiatives and direction.
- Expert in the use of Microsoft Office Suite (Word, Excel, Power
Point, Project, Visio).
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 contactTalent
Acquisitionby calling:(415) 483-8800or byemailingus
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 , Director, Global Regulatory Information Systems, Other , Novato, California
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