Role & responsibilities
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.