Ra Executive

Role & responsibilities1. Regulatory Submissions & ApprovalsPrepare, compile, review, and submit dossiers (CTD/eCTD/ACTD formats) for product registration.Handle drug master files (DMFs), ANDAs, NDAs, INDs and ensure timely submissions to health authorities.Manage variations, renewals, amendments, and post-approval changes.2. Compliance & Regulatory GuidanceEnsure products comply with national and international regulatory guidelines (FDA, EMA, DCGI, CDSCO, WHO, ICH, etc.).Monitor regulatory changes and updates and communicate implications to management.Provide regulatory strategy and support to R&D, QA, QC, and manufacturing teams.3. Documentation & RecordsReview and maintain CMC (Chemistry, Manufacturing, and Controls) documentation.Maintain regulatory records, submissions tracker, and archives.Prepare product labeling, artwork, and packaging inserts in compliance with guidelines.