- Prepare, review, and submit regulatory dossiers, applications, and supporting documentation to ensure timely approvals from relevant health and regulatory authorities.
- Monitor changes in national and international regulations and assess their impact on existing and recent products.
- Coordinate with research, quality assurance, manufacturing, and marketing teams to gather data required for regulatory submissions and renewals.
- Maintain regulatory databases, licenses, registrations, and product files while ensuring accuracy and completeness of records.
- Respond to queries raised by regulatory agencies, support audits and inspections, and implement corrective actions where required.
- Ensure all products comply with applicable laws, guidelines, labeling requirements, and industry standards to facilitate uninterrupted market access.
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