Senior Regulatory Affairs Specialist

Responsible for supporting all aspects of regulatory compliance, submission preparation, and product lifecycle management under the direction of the department management. This role also provides cross-functional support to ensure compliance with pharmacovigilance (drug safety) reporting requirements in accordance with FDA and global regulatory standards.

• Compilation/review of original applications (INDs, NDAs, ANDAs), amendments, supplements, annual reports and product labeling in accordance with FDA and ICH guidelines.
• Assessment of regulatory impact of proposed changes to manufacturing facilities and processes. raw material sources, packaging components, and/or controlled documents.

• Bachelor's degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing).
• Minimum of two years’ experience plus a Regulatory Affairs Certification or four years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment.

• 401k matching
• Health insurance
• Flight privileges

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.