Assoc Director, Regulatory Affairs China - 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: Professional All Job Posting Locations: Beijing, China Job Description: Associate Director, Immunology TA, China Regulatory Affairs   Key Responsibilities 1. Regulatory Strategy Development and Execution Develop and execute end-to-end regulatory strategies for assigned immunology assets and indications in China, spanning early development, late-stage development, NDA/BLA submission, review, approval, and post-approval lifecycle management. Provide strategic input to global regulatory strategy plan, asset development plan, and project-related discussions to ensure China-specific considerations are incorporated early and effectively. Identify opportunities to optimize regulatory pathways, accelerate regulatory approvals, enhance registration success, and maximize patient access. Assess regulatory risks and uncertainties; collaborate with cross-functional teams to develop and implement effective mitigation plans. Provide regulatory leadership to address complex regulatory challenges and drive the resolution of critical regulatory issues. 2. Regulatory Expertise and Strategic Assessment Maintain deep understanding of the China regulatory environment, evolving regulations, health authority expectations, industry trends, competitor intelligence, and the immunology therapeutic area. Monitor and assess evolving regulatory requirements, policies, and agency expectations that may impact product development and registration. Translate changes in the regulatory environment into actionable recommendations and regulatory strategy adjustments to support development, approval, and lifecycle management of assigned assets. 3. Regulatory Submission and Approval Develop China regulatory submission strategy and timeline for assigned assets and get alignment with cross-functional stakeholders across China, regional and global teams. Partner with RE, RMC and NGS teams to deliver regulatory submissions, including CTA, NDA/BLA, supplements, variations, and renewals, and achieve regulatory milestones. Ensure regulatory activities are effectively planned, tracked, and executed to support timely approvals. Review key submission documents, health authority response and labeling content to ensure scientific rigor, quality, consistency and regulatory compliance. 4. Health Authority Interaction Develop and execute health authority interaction strategies, including consultation meetings and regulatory communications. Lead interactions with regulatory agencies to facilitate alignment on development plans, submission strategies, and key regulatory issues. Develop and coordinate high-quality, data-driven responses to health authority questions and information requests. Lead the preparation of briefing books, presentation materials, and supporting documentation for regulatory agency meetings. 5. Stakeholder Management and Business Partnership Represent China Regulatory Affairs on Global Regulatory Teams, China Project Teams, and other cross-functional forums for assigned assets. Act as a strategic partner to cross-functional and business teams, ensuring