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Regulatory Affairs: Department Models and Structures

  • ID: 3920178
  • Report
  • Region: Global
  • 56 pages
  • Industry Standard Research (ISR)
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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
Note: Product cover images may vary from those shown
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1. Methodology
- Respondents’ Company Size
- Interviewee Titles
- Interviewee Responsibilities
- Potential Best Practices

2. Introduction

3. Understanding The Regulatory Affairs Function

4. Regulatory Affairs Employees
- Educational Background
- Employee Qualities
- Key Takeaways

5. Regulatory Affairs Goals
- Top Regulatory Affairs Goals
- Goals Related to the Company
- External Goals
- Signs of a Good Year
- Key Takeaways

6. Role Of Regulatory Affairs Throughout The Lifecycle Of A Medication
- Clinical Development
- Submission
- Post-Approval
- Regulatory Affairs Involvement Timeline
- Regulatory Affairs’ Involvement in the Manufacturing
- Process
- Key Takeaways

7. Regulatory Affairs Department Benchmarking

8. Regulatory Affairs Structure
- Common Regulatory Affairs Global Structures
- Regulatory Structures Continued
- Geographic Alignment

9. Division Of Work
- Regulatory Strategy
- Regulatory Operations
- Chemistry Manufacturing and Controls (CMC)
- Labeling
- Ad/Promo
- Additional Roles
- Unique Sub-departments
- Headcount
- Number of Regulatory Affairs Employees

10. Organizational Alignment
- Research & Development
- Product Development/Development Ops
- Medical Affairs
- Executive Leadership/CEO
- Comparison of Regulatory Affairs Locations
- Key Takeaways

11. Outsourcing Behavior
- Reasons for Outsourcing
- Vendors
- Vendor Attributes
- Key Takeaways

12. Regulatory Affairs Budget
- Size of Budget
- Changes to the Regulatory Affairs Budget
- Budget Source
- Key Takeaways

13. Department Challenges
- Global Complexity
- Changing Requirements
- Grey Area
- Staff Resources
- Balancing Act
- Being Heard
- Key Takeaways

14. Future Predictions
- Combination Products
- Leaner Organizations
- A Joint Approach
- More, More, More
- Worth Mentioning

15. Best Practices & Recommendations
- Regulatory Affairs Employees
- Regulatory Affairs Goals and Involvement
- Regulatory Affairs Work
- Department Structure
- Outsourcing Behavior
- Budget
- Proposed Solutions to Challenges
Note: Product cover images may vary from those shown
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