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Job Description Summary

The Regulatory Affairs Director is a key leadership role responsible for driving the end-to-end regulatory strategy and execution for Gilead’s portfolio in China, with a primary focus on oncology and inflammation therapeutic areas. This position plays a pivotal role in shaping the regulatory pathway for both early- and late-stage assets, including clinical development support, NDA/BLA submission and approval, lifecycle management, and proactive engagement with CDE/NMPA and other local health authorities. The incumbent will serve as the China Regulatory TA lead, ensuring alignment between global regulatory strategy and local requirements, while accelerating patient access to innovative therapies.

Key Responsibilities

Lead the development and implementation of comprehensive regulatory strategies for assigned products and programs in oncology and inflammation, from pre-IND/IND, NDA/BLA through approval and post-marketing phases, ensuring alignment with global plans and local regulation requirements.

Serve as the China Affiliate Regulatory TA Lead for complex or high-priority molecules, indications, or development programs, providing strategic input to cross-functional teams including Clinical Development, CMC, Pharmacovigilance, and Commercial.

Drive end-to-end NDA/BLA submissions and regulatory approvals, including leading cross-functional teams in dossier preparation, responding to HA questions, managing RTQ processes, and supporting inspection readiness.

Lead and manage all interactions with CDE/NMPA and other local health authorities, including pre-IND, pre-NDA, major milestone meetings, and ad hoc communications; act as the primary regulatory point of contact for regulatory authorities in China.

Oversee timely and compliant submission of clinical trial applications, amendments, annual reports, and other trial-related documents to ensure uninterrupted clinical development.

Guide the preparation of key regulatory documents, including briefing packages, meeting requests, responses to information requests, and risk-benefit analyses.

Proactively monitor and interpret evolving local regulatory requirements, guidance, and policies, and ensure rapid integration into China regulatory strategies; contribute to shaping new regulations through constructive engagement.

Provide regulatory input into promotional materials review and lifecycle planning, ensuring compliance with approved labeling and local advertising regulations.

Represent Regulatory Affairs in cross-functional brand teams and internal governance committees, contributing to product positioning and launch readiness.

Mentor and guide junior regulatory staff; champion regulatory excellence and continuous improvement initiatives across processes, systems, and tools.

Stay ahead of competitor landscape and regulatory trends in China, providing insights that inform strategic decision-making.

Maintain close collaboration with global key stakeholders, such as GRL, GDL, and PSL, to provide timely China regulatory input and ensure alignment between local strategy and global development plans.

Qualifications and Skills

Bachelor’s degree or higher in Pharmacy, Life Sciences, Medicine, or a related scientific field; advanced degree (Master’s or PhD) preferred.

Minimum of 15 years of progressive experience in pharmaceutical regulatory affairs, with at least 8 years focused on oncology drug development and registration in China.

Strong track record of leading successful NDA/BLA submissions and managing NMPA review processes, including responding to HA inquiries and participating in regulatory meetings.

In-depth understanding of China drug registration regulations (NMPA), ICH guidelines, and global regulatory standards.

Demonstrated ability to develop and execute innovative regulatory strategies in complex, fast-changing environments.

Proven experience in leading cross-functional teams and influencing outcomes without direct authority.

Excellent written and verbal communication skills in English and Mandarin; ability to present complex regulatory concepts clearly and persuasively.

Strategic thinker with strong problem-solving abilities, attention to detail, and a results-driven mindset.

Highly adaptable, proactive, and capable of managing multiple priorities under tight timelines.

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