Job Summary

A clinical research organization is searching for a person to fill their position for a Remote Regulatory Labeling Director.

Candidates will be responsible for the following:

• Providing labeling expertise, leadership and guidance to team
• Developing and managing regulatory labeling function
• Building and maintaining strong collaborative relationships with key internal and external stakeholders

Applicants must meet the following qualifications:

• Bachelor’s degree or international equivalent
• 15 years’ relevant experience including 7 years formal people management experience
• Detailed understanding of pharmaceutical drug or device development, product maintenance, and global regulations and operations
• Expertise in global guidance relevant to labeling, drug development and commercialization of prescription medicines and/or devices
• Excellent understanding of applicable labeling requirements and guidance
• Ability to strategize, communicate internally and with multiple clients on global labeling