DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Regulatory Affairs: Department Models and Structures" report to their offering.
13 experienced Regulatory Affairs professionals were interviewed at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function. This report was designed 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:
- - 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
Key Topics Covered:
1. Methodology
2. Introduction
3. Understanding The Regulatory Affairs Function
4. Regulatory Affairs Employees
5. Regulatory Affairs Goals
6. Role Of Regulatory Affairs Throughout The Lifecycle Of A Medication
7. Regulatory Affairs Department Benchmarking
8. Regulatory Affairs Structure
9. Division Of Work
10. Organizational Alignment
11. Outsourcing Behavior
12. Regulatory Affairs Budget
13. Department Challenges
14. Future Predictions
15. Best Practices & Recommendations
For more information about this report visit http://www.researchandmarkets.com/research/629sjq/regulatory
