Regulatory Submissions & Publishing Specialist

Jackson Healthcare; Bristol (TN); On-site; USD 70,000 - 90,000; Full time

Job summary

OverviewUSAntibiotics, a member of the Jackson Healthcare family, is seeking a Regulatory Affairs professional to support FDA submissions and lifecycle management for Amoxicillin products. You will compile and publish regulatory documents, coordinate with cross-functional teams, and ensure CTD modules meet FDA/ICH guidelines.

Responsibilities include authoring/Reviewing NDA/ANDA filings, amendments, and labeling packages, managing electronic submissions, and interfacing with FDA and other

Qualifications

• Bachelor's degree in a scientific field required.
• Minimum of one year regulatory affairs experience, or two years plus RAC.
• Experience preparing FDA regulatory submissions (INDs, NDAs, ANDAs) preferred.

Responsibilities

• Prepare and publish FDA submissions (NDA/ANDA filings, amendments, supplements, annual reports, labeling) per FDA/ICH guidelines.
• Publish electronic submissions using eCTD software; build/validate eCTD sequences and resolve publishing errors.
• Interface with cross-functional teams to compile CTD modules and regulatory dossiers.
• Assess regulatory impact of changes to facilities, processes, materials, packaging, and controlled documents.
• Communicate with FDA and other regulatory agencies; manage document control.

Skills

Regulatory knowledge

Technical writing

Project management

Communication

Education

Bachelor's degree in a scientific field

Regulatory Affairs Certification (RAC)

Tools

eCTD software

SAP

Adobe Acrobat

Job description

OverviewUSAntibiotics, a member of the Jackson Healthcare family, is seeking a Regulatory Affairs professional to support FDA submissions and lifecycle management for Amoxicillin products. You will compile and publish regulatory documents, coordinate with cross-functional teams, and ensure CTD modules meet FDA/ICH guidelines.

Responsibilities include authoring/Reviewing NDA/ANDA filings, amendments, and labeling packages, managing electronic submissions, and interfacing with FDA and other