Regulatory Submissions Specialist — FDA/eCTD Expert

Parker Staffing, LLC.; Belle Brook Estates (TN); On-site; USD 55,000 - 75,000; Full time

Job summary

Parker Staffing, LLC. seeks an Associate Regulatory Affairs Specialist for a Bristol, TN site. You will support regulatory submissions, compliance, and product lifecycle management in a pharmaceutical setting.

The role requires a science degree and relevant regulatory experience. This is an onsite, direct-hire position with potential FDA reporting responsibilities and cross-functional coordination.

Qualifications

• Bachelor’s degree in a scientific discipline (chemistry, biology, microbiology, pharmacy, nursing, or related).
• 1+ year regulatory affairs certification or 2+ years pharma/FDA-regulated experience.
• Knowledge of FDA/EMA regulations, ICH guidelines, and cGMP.

Responsibilities

• Prepare, review, and submit regulatory documents to the FDA (INDs, NDAs, ANDAs, amendments, etc.).
• Publish and validate electronic submissions using eCTD software.
• Coordinate with cross-functional teams to ensure timely submissions and regulatory compliance.
• Support CTD Modules 2 and 3 and other dossier content.
• Maintain controlled documents and submission records in DMS.

Skills

Regulatory knowledge

Technical writing

Project management

Communication skills

Education

Bachelor’s degree in a scientific discipline

Tools

eCTD publishing software

Adobe Acrobat

Microsoft Office

SAP

Job description

Parker Staffing, LLC. seeks an Associate Regulatory Affairs Specialist for a Bristol, TN site. You will support regulatory submissions, compliance, and product lifecycle management in a pharmaceutical setting.

The role requires a science degree and relevant regulatory experience. This is an onsite, direct-hire position with potential FDA reporting responsibilities and cross-functional coordination.