Key Responsibilities:
Prepare, compile, and review regulatory submissions (CTD/eCTD formats) for product registrations, renewals, and variations as per regional and international guidelines.
Ensure timely submission and follow-up of applications with regulatory authorities.
Maintain up-to-date knowledge of changes in drug regulatory settings and communicate impacts to relevant departments.
Coordinate with cross-functional teams (R&D;, QA, QC, Manufacturing, Supply Chain) to gather necessary documentation.
Maintain regulatory documentation, databases, and records in compliance with internal procedures and regulatory standards.
Assist in handling product labelling, artwork approvals, and packaging compliance.
Respond to regulatory queries and deficiencies from health authorities in a timely manner.