Regulatory Submissions Specialist – FDA & eCTD Publishing

USAntibiotics, LLC; Bristol (TN); On-site; USD 70,000 - 100,000; Full time

Job summary

USAntibiotics, LLC is seeking a Regulatory Affairs professional to support the preparation, publishing, validation and submission of FDA regulatory documents. You will manage product and submission lifecycle under the direction of the department director, interfacing with cross-functional teams to ensure high-quality dossiers.

Responsibilities include compiling NDA/ANDA filings, publishing electronic submissions, validating eCTD sequences, and assessing regulatory impacts of changes to

Qualifications

• Bachelor's degree in a scientific field is required.
• Minimum 1 year experience plus RAC or 2 years in pharma/cGMP environment.
• Experience authoring/compiling FDA submissions (INDs, NDAs, ANDAs).
• Proficient in eCTD publishing and regulatory document management.

Responsibilities

• Author, review and compile FDA submissions (NDA/ANDA filings, amendments, supplements, annual reports, DMF updates, labeling packages and PADERs).
• Publish electronic submissions using eCTD software.
• Build and validate eCTD sequences and perform technical validation check prior to submission.
• Resolve any publishing validation errors and submission deficiencies.
• Assessment of regulatory impact of proposed changes to manufacturing facilities and processes, raw material sources, packaging components, and/or controlled documents.
• Support interactions with FDA and other regulatory agencies.
• Additional responsibilities as assigned by management.

Skills

Regulatory submissions

FDA interactions

eCTD publishing software

CTD/ICH guidelines

Regulatory documentation

Cross-functional collaboration

Technical writing

Project management

SAP experience

Education

Bachelor's degree in a scientific field

Regulatory Affairs Certification

Tools

eCTD publishing software

Adobe Acrobat

SAP

Job description

USAntibiotics, LLC is seeking a Regulatory Affairs professional to support the preparation, publishing, validation and submission of FDA regulatory documents. You will manage product and submission lifecycle under the direction of the department director, interfacing with cross-functional teams to ensure high-quality dossiers.

Responsibilities include compiling NDA/ANDA filings, publishing electronic submissions, validating eCTD sequences, and assessing regulatory impacts of changes to