Regulatory Affairs: Department Models and Structures


ISR interviewed 13 experienced Regulatory Affairs professionals at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function.  ISR has designed this report to be used as a benchmarking tool for companies to compare their Regulatory Affairs functions to those of other organizations. Key takeaways include:

  • Identify how your company’s approach to Regulatory Affairs may be different from a typical industry approach and the benefits and drawbacks that may result
  • Gather information on unique Regulatory Affairs structures and best practices employed by other organizations, which may be used to improve or streamline the function
  • Compare your company’s Regulatory Affairs department size, structure, resources and approach to those of other companies
  • Regulatory Affairs department role, operations, and structure, including:
    • Division of work within the Regulatory Affairs sub-departments and the employee attributes that contribute to success
    • How different Regulatory Affairs departments are structured, why different structures are utilized and best practices to apply at your organization
    • Outsourcing behavior: reasons for outsourcing and vendor selection
    • Future predictions for the department
  • The components that impact the size of the Regulatory Affairs budget, estimates, and influencing factors to budget changes
  • Regulatory Affairs department challenges, such as global complexity, staff resources, and changing requirements
  • Best Practices for new hires, involvement timelines, work challenges and proposed solutions, department structure, and outsourcing behavior
  • Understand how your company’s approach to Regulatory Affairs may be different from a typical industry approach and use the information to improve the function
  • Compare the size of the department, the structure, division of work and resources to the Regulatory Affairs function at other Top 50 pharmaceutical companies
  • Learn the Best Practices that have contributed to Regulatory Affairs departments success’ and adopt best practices that may improve your company’s Regulatory Affairs deparment

ISR understands that you’re looking for confidence in your market research. With ISR, you’ll consistently receive

  • Focused Domain Expertise — We’ve operated in pharmaceuticals for over 15 years and because it’s our sole focus, our domain expertise brings value to the work that “generalist” researchers can’t deliver.
  • Genuine Research Expertise — Our market research experience has developed over 20 years in many dynamic industries.  We capture appropriate sample sizes, given the research objectives, and we use appropriately sophisticated statistics to uncover everything that’s real and to give you confidence in your decisions. Read our Six Questions to Ask About Your Market Research to learn more about why our industry expertise sets us apart.
  • Transparency — If you’re like many, you’ve been disappointed more than once by research providers who fail to live up to their promises, providing you with their “professional judgment” in place of sound data; and suspect contacts instead of real decision-makers. We deliver the beliefs, attitudes, and intentions of people who matter – and we’ll prove it by showing you the titles of your respondents.

For additional questions about any of ISR’s reports or custom research services, please contact us at


Additional information


, ,


There are no reviews yet.

Be the first to review “Regulatory Affairs: Department Models and Structures”