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Director, Global Regulatory Information Systems

Posted on Apr 6, 2021 by Ultragenyx Pharmaceutical Inc.

Cambridge, MA 02138
Immediate Start
Annual Salary

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 (eg InSight Publisher/Viewer and Veeva Vault RIM), excellent business analysis and project management skills.
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 the future.
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 systems projects.
Responsible for the execution and delivery of Regulatory systems projects (new implementations, mergers, upgrades, and enhancements).
Responsible for the daily business administration of Regulatory systems (eg 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 providers.
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 state.
Responsible for driving the documentation and revision of all Regulatory Affairs systems SOPs, and work instructions (WIs) for applicable systems.
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 data standards.
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 cases.
Partner with vendors and/or IT business partners in keeping abreast of technology trends and applicability to business needs.
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 thinking.
Demonstrated ability to organize, prioritize, and execute on projects to completion.
Proven experience in leading organizational change and influencing others.
Strong knowledge of control and management of regulatory-focused content, throughout the product lifecycle stages, SDLC methodologies and CFR Part 11 and Annex 11 compliance.
Proven experience in staff management, coaching and career development.
Excellent judgment and interpersonal skills, consensus and relationship building
Outstanding presentation skills and professional presence.
Veeva Vault Platform Administrator certification, highly desirable.
Bachelors degree (within a life sciences subject or information technology) with 8+ years 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).

Reference: 1152693543

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