注册事务高级经理

Job description

Your Role： In this pivotal role, you will lead the development and execution of regulatory strategies for new product registrations in China, driving approvals that directly advance patient access to innovative therapies. You will own the end-to-end regulatory submission process, from clinical trial applications through to product approval, ensuring the highest quality of filing dossiers and full alignment with both local and global regulatory requirements. You will establish and maintain the processes and infrastructure needed to monitor regulatory review timelines, coordinate responses to authority queries, and ensure strategic objectives are delivered on schedule. Acting as the primary interface between the China regulatory team and Global Regulatory Therapeutic Area functions, you will negotiate directly with regulatory authorities on product labeling to secure optimal outcomes for the Chinese market. Beyond new product registrations, you will manage license renewals and variations for marketed products, supporting the full product lifecycle in line with business objectives. You will contribute to the continuous improvement of regulatory systems, standard operating procedures, and working practices, and ensure all activities are conducted in compliance with applicable policies and standards. Who You Are： • You hold a degree in a Life Science or related discipline, with a higher qualification such as a Master's degree or PhD. • You bring a minimum of 10 years of regulatory affairs experience in the pharmaceutical or biotechnology industry. • You have an excellent understanding of Chinese regulatory regulations, guidelines, and submission requirements. • You have a proven track record of preparing and managing regulatory submissions and successfully achieving product approvals. • You have demonstrated experience engaging and negotiating with regulatory authorities, including the National Medical Products Administration (NMPA). • You communicate fluently in English, both written and spoken, and are able to collaborate effectively with global and local stakeholders