Develop and implement registration plan for new products in China within relevant therapeu-tic areas.
Manage registration submissions for new products registration and clinical trial applications.
Manage registration submissions for license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.
Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.
Establish and maintain direct contact with European / regional regulatory team for information sharing and ensuring timely support.
Undertake interactions and negotiations with Regulatory Authorities to optimize regulatory approvals.
Closely follow up regulation changes and analyze/predict its impact on company registration strategies.
Keep RA Head informed for the progress of regulatory projects, identify and discuss critical issues and potential solutions before implementation.
Contribute to company systems development, support China RA team to develop or enhance regulatory related SOPs, management systems, working procedures, etc. to improve team operational efficiency.