Food and Drug Administration (FDA)
Office of Regulatory Affairs (ORA)


The FDA Commissioner mandated ORA to realign from a geographically-based management structure to a specialized model organized around the commodities that FDA regulates such as biologics, bioresearch monitoring, pharmaceutical products, medical devices, food and tobacco. The realignment required a workforce transformation for 4,000+ employees and leaders. Over a four-year period, Suntiva supported ORA building the individual and organizational capacity to manage and lead in the midst of increasingly complex and accelerating change.

Suntiva Solution

ORA engaged Suntiva to design and execute change management, stakeholder engagement, strategic communications and leadership development support to successfully transition the workforce and supporting processes and programs from the existing to desired future state. Several key initiatives drove adoption and support for the change, including: design and analysis of a baseline workforce survey to identify current workforce capabilities and commodities across 20+ Districts and make data-driven organization design decisions and commodity specialization assignments; execution of organization-wide assessments to identify barriers and drivers for change, increasing stakeholder adoption and engagement; design and implementation of targeted communications, resources and supporting tools that drove stakeholder awareness and understanding; design and facilitation of employee and leadership working groups to define and communicate roles and responsibilities of all major stakeholder groups impacted by the change; and design and delivery of a nine-month Resilient Leadership development program to over 300 senior leaders, midlevel managers, and front-line supervisors. The Resilient Leadership program was divided into six cohorts and included classroom and web-based training, one-on-one coaching, assessments and online collaboration forums for peer support and resources.


Suntiva provided a strong foundation for organizational change by equipping leaders with the tools to lead from strength, manage their own anxiety and sustain leadership efforts over time. Suntiva’s support resulted in a deeper understanding of workforce concerns and areas of resistance that needed to be addressed to successfully implement the new organizational model. As a result, ORA leadership was better positioned to make data-driven decisions on engagement and communication strategies and implementation of changes while preserving the unwavering ORA mission to protect consumers and enhance public health.

Case Study Download

Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) case study here


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