Major Responsibility
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.
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.
3. Provide regulatory input and advice on lifecycle management (LCM) for company products, including variations, renewals, annual reports, labeling updates, and post-approval commitments.
4. Ensure product registration and regulatory affairs activities are conducted in compliance with Lundbeck policies, standard operating procedures, and applicable China laws and regulations.
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.
6. Maintain and develop effective relationships with NMPA and relevant regulatory authorities (CDE, NIFDC, CFDI, CPC, etc.) to facilitate regulatory approvals and issue resolution.
7. Coordinate Health Authority queries, deficiency letter responses, communication meetings, and other regulatory interactions by working closely with HQ and local cross-functional teams.
8. Provide regulatory expertise and support to cross-functional teams for product development, submission strategy, launch readiness, and market maintenance activities.
9. Support other regulatory affairs activities and strategic projects assigned by the line manager.
Qualification
1. Bachelor’s degree or above in pharmacy, medicine, pharmaceutical sciences, life sciences, or related disciplines; advanced degree is preferred.
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.
3. Good understanding of China drug registration regulations, NMPA/CDE requirements, and Health Authority interaction processes.
4. Strong strategic thinking, project management, communication, stakeholder management, and problem-solving skills.
5. Ability to work independently, manage multiple priorities, and drive cross-functional alignment under tight timelines.
6. Good command of written and spoken English.
Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.
Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.
Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries.
For additional information, we encourage you to visit our corporate site www.lundbeck.com
