Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions.Successfully implement submission strategies to acquire regulatory and ethics committee approvals. Forecast timelines for the critical activities. Liaise with regulatory authorities and investigators to facilitate approval processes.Collaborate with cross-functional teams to ensure timely and accurate documentation, optimise study startup timelines.Obtain and review essential documents, ensure systems updation and filing.Monitor and ensure compliance with local and international regulations.Work and drive the amendments and support the ongoing submissions, notifications for the ongoing studies.Provide guidance and support to project teams on local regulatory and GCP requirements, timelines and strategy.