Associate Regulatory Affairs Manager/RA manager

Job description

• 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.