Developing Superior Regulatory and Global-Trade Compliance Operations: Investment and Service Levels

KEY TOPICS

• Regulatory Compliance Staffing & Investment
• Regulatory Compliance Structure
• Regulatory Compliance Process & Service Levels
• Global Trade Compliance Staffing & Investment
• Global Trade Compliance Process & Service Levels

• Please estimate the total number of FTEs that work in different parts of your company's Regulatory Compliance and Global Trade Compliance functional areas respectively
• Estimate the average number of direct reports at each supervisory level in your organization by area during 2019
• How has your functional area headcount changed in the past 3 years?
• How has the total spend of your company's Regulatory and Global-Trade Compliance functional spending changed over the past 3 years?
• What forces or issues have been driving the percentage changes in your company's functional staffing and spending during the past three years?
• How is your Regulatory Compliance function structured in your company?
• When dealing strictly with the life science market segments, please select the phases across the entire regulatory value chain of a product in which your regulatory compliance is involved
• For each of the selected points in the regulatory value chain of a product, which regulatory agencies do you engage with to prevent compliance issues?
• Please estimate how many full-time equivalent employees (FTEs) are devoted to regulatory compliance in your business development group
• Please estimate how much of the total regulatory compliance and trade compliance functions’ efforts are devoted to the listed activities
• Which of the listed Global Trade Compliance software providers support your group?

• Regulatory Compliance: Regulatory organizations typically interact with 3 to 9 agencies on average across the product lifecycle.

METHODOLOGY

Best Practices, LLC engaged 24 leaders from 22 life sciences and medical device companies in this research through a benchmarking survey. More than 80% of the benchmark class serves at the director level and above.

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