Director of Regulatory Affairs

Job Summary

A company is looking for a Director of Regulatory Affairs - Clinical.

Key Responsibilities

• Author and review regulatory submissions and lead preparation for FDA CVM meetings
• Provide regulatory guidance on clinical studies and manage regulatory risks across functions
• Oversee regulatory records and serve as the internal subject matter expert for FDA CVM clinical requirements

Required Qualifications

• Bachelor's degree in a relevant field or equivalent experience
• 10+ years of regulatory affairs experience in animal health
• Hands-on experience with INADs and regulatory submissions
• Extensive knowledge of FDA CVM regulatory pathways and policies
• Ability to mentor junior team members while operating as a high-level individual contributor