QC Contractor

QC Contractor Katalyst Healthcares & Life Sciences - 4.0 Avenel, NJ Job Details Contract 5 hours ago Qualifications FDA submissions Regulatory submission editing and review Document quality checks Content review

Full Job Description Job Description:

Our Client is seeking a Quality Control (QC) professional to support regulatory submission activities by performing quality review of submission documents and ensuring completeness, accuracy, consistency, and compliance with applicable regulatory requirements.

Responsibilities:

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.