Job Description
Senior RA Manager
Requistion ID: 7974
Location:
Beijing, N/A, CN
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 regulat...
Requistion ID: 7974
Location:
Beijing, N/A, CN
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 regulat...