US Regulatory Affairs Manager

Job Summary

A company is looking for a Manager/Associate Director, US Regulatory Affairs.

Key Responsibilities:

• Lead regulatory strategy and submissions for US FDA regulated veterinary pharmaceutical and biopharmaceutical products
• Collaborate with internal teams to provide regulatory input and establish product profiles and claims
• Coordinate applications and responses to FDA-CVM inquiries, facilitating global registration activities

Required Qualifications and Education:

• Master's or DVM and/or PhD in a relevant scientific discipline
• 8+ years of experience in US regulatory affairs and interaction with FDA-CVM
• Knowledge of regulatory procedures for veterinary medicinal products
• Understanding of safety/efficacy and dossier assembly for FDA-CVM
• Experience in biopharmaceutical veterinary product development is desirable