Michigan Licensed Biologics Manager

A company is looking for a Manager I - US Biologics Regulatory Affairs. Key Responsibilities Develop regulatory strategy and manage US regulatory submissions for veterinary biological and biopharmaceutical products Provide regulatory input during early project phases and liaise with global teams for label claims and product materials Support regulatory processes for biological product labeling, advertisements, and promotional materials Required Qualifications MS in biology, animal science, or related science; PhD or DVM is desirable Minimum of 5 years of experience with veterinary biological products, preferably in regulatory affairs Veterinary clinical experience will also be considered Understanding of USDA regulatory requirements and veterinary biological development process is desirable Familiarity with standard software and communication technologies

Apr 10, 2025 - 18:02

A company is looking for a Manager I - US Biologics Regulatory Affairs. Key Responsibilities Develop regulatory strategy and manage US regulatory submissions for veterinary biological and biopharmaceutical products Provide regulatory input during early project phases and liaise with global teams for label claims and product materials Support regulatory processes for biological product labeling, advertisements, and promotional materials Required Qualifications MS in biology, animal science, or related science; PhD or DVM is desirable Minimum of 5 years of experience with veterinary biological products, preferably in regulatory affairs Veterinary clinical experience will also be considered Understanding of USDA regulatory requirements and veterinary biological development process is desirable Familiarity with standard software and communication technologies