Director, China RA TA Leader-Immunology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: People Leader All Job Posting Locations: Beijing, China Job Description:

Define & shape China regulatory strategy and orchestrate the execution across the Immunology Therapeutic Area (IMM TA) portfolio for R&D development, business success and priorities and lifecycle management, to unlock patient access and commercial value. Own the end-to-end China regulatory strategy for the entire Immunology portfolio and drive all regulatory activities. Set the overarching regulatory roadmap aligned with global R&D and commercial business priorities, with full accountability for shaping the regulatory direction of multiple assets across the immunology portfolio. Build robust China Immunology TA regulatory capabilities and regulatory insights. Proactively monitor changes to the regulatory environment and industry landscape, identify strategic opportunities, guide the team to deliver technical input, translate expert recommendations into actionable regulatory strategies, and drive the implementation. Lead the team to strategically define comprehensive regulatory pathways and continuously pursue innovative regulatory approaches (e.g., priority review, Breakthrough Therapy, rare disease / orphan designation, pilot program, etc). Facilitate HA meetings (e.g., NMPA pre-IND and pre-NDA consultation meetings) supported by team members with well-prepared pre-meeting strategy and targeted communication plans. On one hand, coordinate internal communication and resources to achieve defined meeting objectives, secure favorable regulatory feedback for asset development. On the other hand, execute post-meeting action plans, maintain ongoing follow-up with health authorities, and deliver on meeting outcomes. Guide team to evaluate target submission and approval timelines, POS, and change management based on R&D and business strategy requirements and ensure timely alignment with key stakeholders. Lead submission timelines and cadence planning, identify critical-path items and bottlenecks, mobilize internal and external resources to deliver IND/NDA/Variation and other submission milestones, and provide timely updates to stakeholders. Drive the development of a comprehensive labeling strategy with team members. Strategically design label claims and supporting evidence packages aligned with clinical data, scientific rationale and company positioning. Lead cross-functionally aligned HA negotiations to secure a label that maximizes patient access and product therapeutic value. Lead the team to anticipate HAQs proactively, build evidence matrix and define optimized response strategy. Lead cross-functional teams to deliver robust, consistent responses to verbal and written HA queries to protect regulatory submissions. Partner with CMCRA and CMC teams (e.g., DPDS, Supply Chain, Quality) to co-develop the China CMC regulatory strategy in Immunology RA, identify CMC-related risks and define mitigation plans. Integrate the CMC strategy into the overall regulatory strategy to secure regulatory approvals for Immunology TA. Regulatory