With China's biopharmaceutical industry achieving world-class standards, it can meet the huge demand for high-quality yet affordable products in South East Asia. Our vision is to be a strategic alliance between China and Singapore to promote the production and sales of products in the region and to the world.
- 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.
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