Duty/Responsibilities

Timely obtain approvals for genome edited crop products for import in China (40%):

• Understanding of genome edited regulatory guidelines, standards and data requirements and work with High Performance Regulatory Team to ensure all necessary studies are planned to enable timely data provision required in applications.
• Compile extensive regulatory assessment data packages for product approval/registration that conform to appropriate government guidelines and standards for genome edited product safety assessment.
• Obtain genome edited in-country studies permits, ensure testing materials imported, and studies performed on time and finally obtain the import approvals.

Promote a favorable environment for import approvals of genome edited products in China (30%):

• Understand global and China genome editing regulations and policies and build good working relationships with key regulators and stakeholders in China.
• Proactively track establishment of new regulations, guidelines and standards concerning genome edited products and their impact on data requirements; coordinate comments/activities to influence the data requirement in a science-based principle
• Serve as technical resource to support genome editing technology advocacy efforts in China. 

Provide support and assist biotech team on regulatory affairs activities (30%):                                                                                                                         

• Coordinate and organize consultations activities with local experts to resolve technical issues.
• Facilitate collaboration with external stakeholders for smooth project progress by project planning, organizing regular meetings and sharing updates with all parties involved.
• Perform other tasks as directed by the China biotech regulatory team leader.