• Integrates and generate the China Regulatory Oncology Disease Area strategy with strong scientific/medical, and business perspectives to achieve company BioPharma objectives and to apply potentials from China Regulatory Reform.
• Translates strategy into project goals and objectives, identifies resources and leads to organization to focus on objectives. Assures that the organization follows through to achieve high quality execution of plans
• Leads, writes, and contributes and add value to the writing of scientific documents for regulatory purposes, including regulatory documents for CTA, NDA/BLA submissions, health authority responses, and health authority meeting materials (such as briefing books).
• Executes negotiations with China FDA in line with BMS strategy and provides strategic directions and supervises negotiations with other relevant regulatory agencies for assigned project.
• Provides direction for maximizing opportunities within projects (e.g. life-cycle) and across the geographical area to support the productivity priorities.
• Communicates actively and timely with China R&D head, Cross functions heads, China Full Development Team (FDT), Global Development Teams (early and late phases) in full alignment with cFDA and global FDT on China regulatory strategy, to meet submission and approval objectives of CTA/NDA/BLA.
• Participates actively in and represents Global/China Regulatory Sciences for their project on various multi-functional committees or teams (e.g., Brand Team, Regional Operating Committee, if applicable).
• Develops strong working relationships with key stakeholders both within and outside the company. Builds and maintains strong relationships with alliance partners when applicable.
• Expert level of China regulatory requirements and fully understand global/ICH regulatory requirements.
• Establishes cooperative partnership between China and global teams/functions; ensures China-specific regulatory requirements are implemented strategically and operatively.

Watches, anticipates and acts on trends and changes in the China and international regulatory environment which may have an impact on the business and communicate timely with the local and global partners.