Regulatory Affairs Specialist — FDA Submissions & Compliance

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

Job summary

Parker Staffing seeks a Regulatory Affairs Specialist for a Bristol, TN pharmaceutical client. You will support regulatory submissions and ensure compliance with FDA, ICH, and eCTD standards while coordinating with cross-functional teams.

Qualified candidates have a science degree and 2+ years of regulatory experience (or 4+ years in pharma). The role is on-site, direct-hire with a Monday–Friday schedule and a salary range of $55k–$75k.

Qualifications

• Bachelor’s degree in a scientific or healthcare-related field.
• 2+ years of regulatory affairs experience with certification, or 4+ years in pharma.
• Knowledge of FDA, ICH, cGMP and submission requirements.
• Experience with post-approval submissions, labeling, and promotional material review.
• Familiarity with eCTD publishing and electronic submissions.
• Strong organizational and project management skills.
• Ability to manage multiple priorities with minimal supervision.
• Strong written and verbal communication skills.
• Experience with SAP or regulatory publishing software is a plus.

Responsibilities

• Prepare and review regulatory submissions, including applications, amendments, supplements, annual reports, and labeling.
• Ensure submissions meet FDA, ICH, and eCTD requirements.
• Assess regulatory impacts of manufacturing, material, packaging, and process changes.
• Support post-approval product lifecycle and labeling activities.
• Coordinate with internal teams, external partners, and regulatory agencies.
• Assist with FDA correspondence and responses to regulatory requests.
• Support pharmacovigilance and required safety reporting.
• Review promotional and labeling materials for compliance.
• Monitor regulatory updates and maintain submission records.
• Manage multiple regulatory projects and deadlines.
• Other duties as assigned

Skills

Regulatory expertise

Documentation

Project management

Strong communication

Attention to detail

Education

Bachelor’s degree in a scientific or healthcare-related field

Tools

Microsoft Office

Adobe Acrobat

Database systems

SAP

eCTD publishing software

Job description

Parker Staffing seeks a Regulatory Affairs Specialist for a Bristol, TN pharmaceutical client. You will support regulatory submissions and ensure compliance with FDA, ICH, and eCTD standards while coordinating with cross-functional teams.

Qualified candidates have a science degree and 2+ years of regulatory experience (or 4+ years in pharma). The role is on-site, direct-hire with a Monday–Friday schedule and a salary range of $55k–$75k.