RAQA Intern

Descrizione del lavoro:

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
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* 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