Regulatory Affairs Business Support Specialist

Lake County, IL, US
Sep 26, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Regulatory Affairs Business Support Specialist, as a member of the RA Business Support team, provides business-centric support for globally deployed processes and supporting technologies across Regulatory Affairs. Working under the direction of the RA Business Support Lead, this role will help coordinate and deliver appropriate solutions to improve users' ability to assimilate process and technology within the context of their jobs and will support a metrics portfolio that allows management insight into the daily operations of RA. This role will work alongside other Specialists, some of which may be in different geographic locations.

Key Responsibilities Include:
  • Provides business support for globally deployed applications, including helping to identify and provide appropriate training, gaining access to applications, and obtaining access to appropriate application components in support of global user community. Each specialist will support one or more geographical areas (US/Canada; Latin America; Western Europe; Eastern Europe, Middle East & Africa; and Japan/Asia Pacific)
  • Triages and resolves business process questions within the context of deployed applications; closely collaborates with project team members, business SMEs, and IT partners to identify and deliver solutions.
  • Identifies, monitors, and summarizes support Service Level Agreements (SLAs); effectively uses this information to implement and measure continuous improvement across functions.
  • Analyzes trends in business support metrics and questions and helps implement long-term change management strategies to support application super users/local experts and create process improvements within the organization
  • Analyzes and reports key regulatory activities and events for executive level leaders across the organization by creating and managing executive level data summaries or dashboards.
  • Supports Business Process Owners in the gathering and reporting of business process metrics; identifies and helps implement process improvement initiatives
  • Possesses a working knowledge of product life-cycle, business processes, and regulations in one or more RA sub-functions and collaborates with project team members to gain deep understanding of existing, new, and revised processes and supporting technologies. Utilizes this understanding to provide and improve business support capabilities.
  • Knows and understands existing and upcoming process and technology initiatives to effectively scale and enhance existing business support capabilities.
  • Ability to create, maintain and deliver clear and concise in-person and electronic based training for global regulatory users
  • Works well in a global and matrix team environment; interacts effectively across RA sub-functions and related organizations across the globe.


  • Bachelor's degree in relevant field (Business, Computer Science, Engineering, Information Management or Statistics)
  • 5+ years related experience
  • Strong communication skills, both oral and written
  • Experience working in a global, matrix environment
  • Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy


  • ITIL certifications
  • SharePoint-related courseware/certifications
  • Six-sigma certification
  • 5 years working in Regulatory Affairs or related field
  • Information Management Systems, Engineering, Business Operations, Project
  • Management or related field preferred
  • 3-5 years working as a data analyst or business data analyst
  • Strong knowledge of MS Excel including the ability to create pivot tables, manipulate large data sets, and MS PowerPoint to clearly communicate the story of the data
  • Knowledge of statistics and experience using statistical packages for analyzing datasets
  • Adept at queries, report writing and presenting findings

Equal Opportunity Employer Minorities/Women/Veterans/Disabled