About this role
<p>Major Responsibility</p> <p> </p> <p>1. Lead and manage Regulatory Affairs activities for assigned marketed products and pipeline projects in China, including registration strategy, submissions, lifecycle management, and Health Authority interactions.</p> <p>2. Independently develop filing and regulatory strategies in collaboration with HQ and local cross-functional teams; drive alignment on submission plans, timelines, and regulatory requirements.</p> <p>3. Provide regulatory input and advice on lifecycle management (LCM) for company products, including variations, renewals, annual reports, labeling updates, and post-approval commitments.</p> <p>4. Ensure product registration and regulatory affairs activities are conducted in compliance with Lundbeck policies, standard operating procedures, and applicable China laws and regulations.</p> <p>5. Monitor and interpret NMPA/CDE regulatory requirements, policy changes, and competitor regulatory information; provide timely assessment and recommendations to support project and business decisions.</p> <p>6. Maintain and develop effective relationships with NMPA and relevant regulatory authorities (CDE, NIFDC, CFDI, CPC, etc.) to facilitate regulatory approvals and issue resolution.</p> <p>7. Coordinate Health Authority queries, deficiency letter responses, communication meetings, and other regulatory interactions by working closely with HQ and local cross-functional teams.</p> <p>8. Provide regulatory expertise and support to cross-functional teams for product development, submission strategy, launch readiness, and market maintenance activities.</p> <p>9. Support other regulatory affairs activities and strategic projects assigned by the line manager.</p> <p> </p> <p> </p> <p>Qualification</p> <p> </p> <p>1. Bachelor’s degree or above in pharmacy, medicine, pharmaceutical sciences, life sciences, or related disciplines; advanced degree is preferred.</p> <p>2. At least 8 years of experience in Regulatory Affairs in the pharmaceutical industry, with solid experience in China regulatory submissions and lifecycle management; multinational pharmaceutical company experience is preferred.</p> <p>3. Good understanding of China drug registration regulations, NMPA/CDE requirements, and Health Authority interaction processes.</p> <p>4. Strong strategic thinking, project management, communication, stakeholder management, and problem-solving skills.</p> <p>5. Ability to work independently, manage multiple priorities, and drive cross-functional alignment under tight timelines.</p> <p>6. Good command of written and spoken English.</p>