Zoetis is a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals
Job Summary
Zoetis is a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals.
The CMC Regulatory Specialist plays a critical role in preparing the Site Master File for the Type V Veterinary Master File (VMF) and developing Outlines of Production for the new GMS Atlanta site.
This role conducts domestic and international regulatory compliance activities for Quality Operations with emphasis on FDA (21 CFR) and USDA/APHIS (9 CFR) regulations.
Matching Summary
Zoetis is a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals.
Skills & Requirements
Must-have
FDA (21 CFR) and USDA/APHIS (9 CFR) regulations
prepare and submit regulatory change requests
manage GMS facility documents
Annual Product Reviews
Outline of Production compliance
support regulatory agency audits
Nice-to-have
nurture the world and humankind
advance care for animals
cross-functional team collaboration
high integrity and self-motivation
Key Requirements
Bachelor’s degree or equivalent
5 – 7 years of experience in Quality or manufacturing
Minimum 3 years of relevant regulatory experience
FDA (21 CFR) and USDA/APHIS (9 CFR) regulated environment experience preferred