- Prepare and compile regulatory dossiers for submissions to the US, EU, WHO, and other global markets.
- Support the preparation, review, and maintenance of Drug Master Files (DMFs).
- Review technical documents such as specifications, manufacturing process documents, and spike study reports.
- Draft responses to regulatory queries and coordinate with cross-functional teams for timely submission.
- Ensure all regulatory documents comply with global regulatory guidelines and company procedures.
- Coordinate with QA, QC, Production, and R&D; teams to collect required submission documents.
- Maintain regulatory documentation and support product lifecycle management activities.
- Track submission timelines and ensure assigned activities are completed on schedule.
- Maintain proper records of submissions, approvals, and regulatory correspondence.
- Assist senior team members in regulatory projects and support continuous compliance activities.