Regulatory Affairs Professional

Job description

- Prepare, compile, review, and submit Drug Master Files (DMFs) and amendments as per regulatory requirements. - Compile CTD/eCTD Module 3 documents by coordinating with QA, QC, Production, and RD teams. - Review manufacturing, analytical, and stability documents to ensure accuracy and regulatory compliance. - Prepare responses to regulatory deficiency letters and customer queries within timelines. - Maintain DMF lifecycle activities, including annual updates, amendments, and version control. - Ensure compliance with ICH guidelines, US FDA, EU, and other applicable global regulatory requirements. - Maintain proper documentation and support regulatory inspections and audits. Disclaimer: This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.