Regulatory Affairs Executive

Job description

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.