Senior Manager/associate Director, Regulatory Affairs - Hematology & Oncology Early Development Ta
Johnson & Johnson
Beijing, China
Regulatory strategy development
China regulatory system expertise
Drug development lifecycle management
This role is responsible for end-to-end regulatory strategy and execution for new asset development and lifecycle management in Hematology/Oncology early development TA in China
Job Summary
This role is responsible for end-to-end regulatory strategy and execution for new asset development and lifecycle management in Hematology/Oncology early development TA in China.
The position leads China regulatory interactions, drives high-quality submissions and approvals, monitors regulatory changes, and partners closely with R&D and commercial teams to enable successful drug development and commercial continuity.
Johnson & Johnson provides an inclusive work environment where diversity and dignity of employees are respected and recognized.
Matching Summary
This role is responsible for end-to-end regulatory strategy and execution for new asset development and lifecycle management in Hematology/Oncology early development TA in China.
Skills & Requirements
Must-have
Regulatory strategy development
China regulatory system expertise
Drug development lifecycle management
Health authority interaction
Cross-functional collaboration
Regulatory submissions and approvals
Nice-to-have
Strong communication and influencing skills
Leadership and learning agility
Storytelling and presentation abilities
Growth mindset
Matrix organization experience
Key Requirements
Master’s degree or above in life-science discipline
More than 5 years regulatory affairs experience
Experience in multinational pharmaceutical company
Experience leading regulatory strategy for new assets