Director, Regulatory Affairs

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Key ResponsibilitiesLead the development and execution of China regulatory strategies for assigned early-phase assets and programs, from asset entry and development candidate selection through pre-IND/IND, first-in-human, proof-of-concept and dose-expansion stages. Provide early and proactive China regulatory input into global development plans, including target product profile, indication and population strategy, dose and regimen selection, biomarker strategy, endpoint selection, China enrollment approach, and the timing and design of China participation in global studies. Assess whether and how China can participate in global early-phase studies; identify China-specific regulatory considerations and develop practical mitigation plans to enable timely inclusion of China. Lead regulatory pathway assessments for innovative modalities, novel mechanisms, combination regimens and complex clinical development programs, translating evolving China requirements into clear strategic options and recommendations. Plan and lead interactions with CDE/NMPA and other relevant health authorities, including pre-IND and other milestone consultations; develop meeting objectives, briefing packages, question strategy and follow-up actions. Lead or oversee high-quality and timely IND/CTA submissions, amendments, safety-related submissions, annual reports and other clinical trial regulatory activities, ensuring compliance and continuity of development. Identify regulatory risks, evidence gaps, dependencies and decision points early; develop scenario-based options, escalation recommendations and actionable risk mitigation plans. Monitor and interpret China regulations, technical guidelines, review practices and policy developments relevant to early development, and rapidly integrate insights into asset strategies and portfolio planning. Build strong partnerships with Global Regulatory Leaders, Global Development Leaders, Product Strategy Leads and China cross-functional stakeholders to ensure alignment between local strategy, global development plans and portfolio priorities. Mentor and coach regulatory colleagues, strengthen early-phase regulatory capability within the China RA team, and contribute to regulatory excellence and continuous improvement. Qualifications and Skills Bachelor’s degree or higher in Pharmacy, Life Sciences, Medicine or a related scientific field; an advanced degree is preferred. Director level: typically 12+ years of progressive pharmaceutical regulatory affairs or drug development experience. Associate Director level: typically 10+ years. Level will be determined based on the depth, breadth and impact of relevant experience. Substantial hands-on experience in early-phase drug development and China regulatory strategy, including pre-IND/IND, first-in-human and proof-of-concept programs; experience in oncology and/or inflammation is strongly preferred. Demonstrated ability to shape clinical development strategy, not only manage submissions, and to translate scientific, clinical and regulatory considerations into clear development options and recommendations. Experience leading interactions with CDE/NMPA and preparing high-quality briefing packages, meeting questions, IND/CTA dossiers and responses to health authority inquiries. Strong understanding of China drug registration regulations, ICH guidelines and global drug development principles; familiarity with innovative modalities, combination strategies or biomarker-driven development is an advantage. Proven ability to exercise sound judgment under uncertainty, lead cross-functional discussions, influence global stakeholders and communicate a compelling China perspective in governance and decision-making forums. Excellent written and verbal communication skills in English and Mandarin. Strategic, curious, collaborative and results-oriented, with strong problem-solving skills and the ability to manage multiple priorities in a fast-moving environment. Position SummaryThe Regulatory Affairs Director / Associate Director is a strategic role responsible for shaping and executing China regulatory strategies for early-phase development programs, with a primary focus on oncology and inflammation. The position will provide China regulatory leadership from asset entry and development candidate selection through pre-IND/IND, first-in-human, proof-of-concept and dose-expansion stages, ensuring that China requirements and opportunities are incorporated early into global development plans. The incumbent will partner closely with Global Regulatory, Clinical Development, Clinical Operations, CMC, Nonclinical, Biostatistics, Pharmacovigilance and other functions to enable scientifically robust, operationally feasible and globally aligned development strategies, while establishing a clear pathway toward later-stage development and registration in China. Key ResponsibilitiesLead the development and execution of China regulatory strategies for assigned early-phase assets and programs, from asset entry and development candidate selection through pre-IND/IND, first-in-human, proof-of-concept and dose-expansion stages. Provide early and proactive China regulatory input into global development plans, including target product profile, indication and population strategy, dose and regimen selection, biomarker strategy, endpoint selection, China enrollment approach, and the timing and design of China participation in global studies. Assess whether and how China can participate in global early-phase studies; identify China-specific regulatory considerations and develop practical mitigation plans to enable timely inclusion of China. Lead regulatory pathway assessments for innovative modalities, novel mechanisms, combination regimens and complex clinical development programs, translating evolving China requirements into clear strategic options and recommendations. Plan and lead interactions with CDE/NMPA and other relevant health authorities, including pre-IND and other milestone consultations; develop meeting objectives, briefing packages, question strategy and follow-up actions. Lead or oversee high-quality and timely IND/CTA submissions, amendments, safety-related submissions, annual reports and other clinical trial regulatory activities, ensuring compliance and continuity of development. Identify regulatory risks, evidence gaps, dependencies and decision points early; develop scenario-based options, escalation recommendations and actionable risk mitigation plans. Monitor and interpret China regulations, technical guidelines, review practices and policy developments relevant to early development, and rapidly integrate insights into asset strategies and portfolio planning. Build strong partnerships with Global Regulatory Leaders, Global Development Leaders, Product Strategy Lea