Hiring for Regulatory Affairs

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 R&D <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.