Country approval specialist (Thermofisher)

Roles and Responsibilities

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.