Job Summary
The Regulatory Affairs Manager plays a pivotal role in the development, registration, and ongoing management of products related to animal health. This position is primarily focused on ensuring compliance with USDA Center for Veterinary Biologics (CVB) and FDA Center for Veterinary Medicine (CVM) regulations. The manager is responsible for offering regulatory insights to various interdisciplinary teams and overseeing the creation and submission of necessary regulatory documents.
Responsibilities
- Support the development and lifecycle management of animal health products.
- Ensure compliance with USDA CVB and FDA CVM regulations.
- Provide regulatory guidance to cross-functional teams throughout product development.
- Lead the preparation and submission of various regulatory filings.
Qualifications
- Bachelor’s degree in a relevant scientific field.
- 5-8 years of experience in regulatory affairs specifically within the animal health sector.
- Extensive hands-on experience with USDA CVB regulations.
- Experience in veterinary biologics submissions is essential.
Enzene INC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
