- Prepare compile and coordinate regulatory documents & submissions.
- Manage preparation of CTD, variations, renewals, responses to deficiencies, and other regulatory submissions.
- Compile and review documents for Module 1-5, ensuring completeness consistency and compliance with applicable regulatory requirements.
- Coordinate collection of required documents from QA, QC, Production, and other departments.
- Ensure compliance with Internal SOP’s, regulatory procedures and document management requirements.
- Ensure consistency of Information across regulatory submissions, specifications, manufacturing documents, artworks, labels and other supporting documents.
- Maintain and prepare regulatory trackers, databases, approval records, submission and ensure accurate status updates and timely correspondence emails.
- Review product artwork, labels, cartons, package inserts, and other product related materials from a regulatory perspective.
- Experience - 3 to 4 years