Rxilient Medical Pte Ltd – Regulatory Affairs Intern / Executive

Responsibilities

• Works in the regulatory affairs department on assigned projects and reports to Senior Manager, QARA
• Maintain the regional overview of country registration status and provided periodic status update
• Establish regulatory process to enhance cross-departmental activities and expedite market access and business growth
• Facilitate and track the preparation and documentation for regulatory submissions to government agencies as well as work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, including the variation in regulatory requirements of the many regulated countries in SEA and Greater China.
• Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.
• Collaborates with key staff from Planning, Product Development, Operations, and Legal departments as required.
• Notifies Regulatory Affairs Manager when compliance issues arise or are identified, when regulatory reports are delayed, and when other immediate action is required.
• Performs other related duties as assigned.