QC Contractor

• Perform QC review of regulatory submission documents (e.g., regulatory submission packages and supporting documentation).
• Verify formatting, document consistency, hyperlinks, references, and submission readiness.
• Ensure compliance with FDA, EU, and internal document control requirements.
• Review source documents for accuracy and completeness prior to submission.
• Coordinate with Regulatory Affairs, Quality, Clinical, and Technical teams to resolve document discrepancies.
• Support publishing and submission activities as needed.
• Maintain submission trackers and QC documentation.

Requirements:

• 3+ years of experience supporting Regulatory Affairs, Quality, Document Control, or Regulatory Publishing.
• Experience performing QC reviews of regulatory submissions and supporting documentation.
• Knowledge of FDA and/or EU regulatory submission processes.
• Strong attention to detail and document review skills.
• Experience with eCTD, submission publishing tools, Veeva, SharePoint, or document management systems preferred.

Preferred:

• Experience supporting FDA, EMA, Health Canada, or EU submissions.