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• 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. The Mundipharma story, spanning over six decades, is one that brings together a visionary approach and a pioneering spirit – and is best told through our patients, our employees and the communities in which we serve. Today we are an innovative company, with more than 3,500 employees across the Emerging Markets and a distribution network covering six continents. And this is just the beginning of our story in this region. As an organization, we are all about people. Innovation, continuous improvement, constant learning and sustainability are key to our business and our people are at the core of this. Mundipharma’s culture is dynamic, entrepreneurial, fun and high-performing. If you are someone who is focused and driven, looking to work at a place where you can take ownership, and make a real difference to improving the quality of patients’ lives, then this is the place for you.
Mundipharma
Beijing, China