What are the responsibilities and job description for the QC Contractor position at Katalyst Healthcares & Life Sciences?
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:
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.