Picture of Regulatory Affairs: Department Models and Structures

Regulatory Affairs: Department Models and Structures

October 2016


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

What you will learn
- Regulatory Affairs department role, operations, and structure, including: 
o Division of work within the Regulatory Affairs sub-departments and the employee attributes that contribute to success 
o How different Regulatory Affairs departments are structured, why different structures are utilized and best practices to apply at your organization 
o Outsourcing behavior: reasons for outsourcing and vendor selection 
o 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 

How you can use this report 
- 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