Regulatory Affairs Specialist III, Animal Health
Core
Define and implement regulatory strategy for Animal Health product lines, ensuring compliance with agencies like the USDA.
Role type
Regulatory Affairs Specialist
Builds
Regulatory submissions, compliant labeling, and promotional materials for Animal Health diagnostics
Domain
Animal Health / Veterinary Diagnostics / Regulatory Compliance
Deliverable
client delivery
Required skills
Regulatory strategy creation, USDA regulation expertise, regulatory document preparation, permit/license maintenance, regulatory surveillance, labeling review
Preferred skills
Animal Health Diagnostic experience, Human IVD experience, CE-IVD experience
Technologies
None stated
Responsibilities
Write, coordinate, and submit regulatory documents to agencies; Engage regulators in oral and written communications; Serve as RA subject matter expert on regulations; Coordinate regulatory issue resolution; Conduct trainings on regulated environments; Review and approve labeling and promotional materials; Collaborate with global regulatory professionals
Seniority
Mid-level Specialist