Regulatory Affairs Executive

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.