Senior RA Manager

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.