RAQA Intern

Job description

Work Flexibility: Hybrid Basic understanding of the regulatory requirements under Medical Device Rules, 2017 and the Drugs & Cosmetics Act. Assist in preparing and organizing regulatory documentation and submissions for new products and retentions. Support RA team in remediation activity for existing submissions / approvals Maintain and update regulatory databases, trackers, and filing systems. Conduct research on regulatory guidelines and updates issued by authorities. Track regulatory timelines and maintain submission status reports. Coordinate with internal teams to gather information required for regulatory Support the Regulatory Affairs team with administrative and documentation tasks. Understand the complaint and adverse event reporting requirements and report such events to the competent authority within the stipulated timelines. Understand the BIS registration process and requirements Travel Percentage: 10%