Associate RA Specialist Operations and Publishing

Location: Bristol-Tennessee

Overview

USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We’re always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

Responsible for supporting the preparation, publishing, validation and submission of regulatory documents to the FDA. Will be responsible for product and submission lifecycle management under the direction of department Director. Activities may include but are not limited to:

• Compilation/review of original applications (INDs, NDAs, ANDAs), amendments, supplements, annual reports and product labeling in accordance with FDA and ICH guidelines.
• Interface with cross-functional teams to author, review, and compile high-quality regulatory dossiers (such as CTD Modules 2 and 3) to secure and maintain product approvals from health authorities such as FDA.
• Manage controlled regulatory documents within document management systems.

ROLES & RESPONSIBILITIES: