Associate Regulatory Affairs Manager/RA manager

Mundipharma · Beijing

• 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.