Senior Regulatory Affairs Specialist
USAntibioticsTennessee, United States
Posted November 12, 2025
Full Time
About the Company
USAntibiotics is the only U.S. manufacturer of Amoxicillin and Amoxicillin Clavulanate, commonly known as Amoxil and Augmentin. Based in Bristol, Tennessee, it operates a world-class, 394,000-square-foot antibiotic production facility with the sole focus of making quality, life-saving antibiotics widely available for the benefit of all Americans.
Job Description
Responsible for supporting all aspects of regulatory compliance, submission preparation, and product lifecycle management under the direction of the department management.
Requirements
- Compilation and review of FDA Submissions (e.g., NDA/ANDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages)
- Assessment of regulatory impact of proposed changes to manufacturing facilities and processes
- Compile, review, and format regulatory submissions including Annual Reports, original applications (INDs, NDAs, ANDAs), amendments, supplements, and product labeling in accordance with FDA and ICH guidelines
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- 401k Matching
