gilead

Regulatory Affairs Director – China (Beijing/Shanghai)

Location: Beijing or Shanghai, China
Job Type: Full-Time | Onsite Required
Company: Gilead Sciences

About the Role

The Regulatory Affairs Director is a senior leadership position responsible for defining and executing end-to-end regulatory strategies for Gilead’s China portfolio, with a strong focus on oncology and inflammation therapeutics. This role ensures regulatory excellence across early-stage to late-stage development, including clinical support, NDA/BLA submissions, lifecycle management, and direct engagement with CDE/NMPA and other health authorities. The Director will serve as the Therapeutic Area Regulatory Lead in China, ensuring alignment between global regulatory objectives and local regulatory requirements.

This role is critical for accelerating patient access to innovative therapies and shaping Gilead’s regulatory presence in one of the world’s most dynamic healthcare markets.

Key Responsibilities

• Develop and implement comprehensive regulatory strategies across oncology and inflammation programs from pre-IND/IND to NDA/BLA approval and post-marketing phases.

• Act as the China Regulatory Therapeutic Area Lead for priority assets and high-complexity programs, delivering strategic guidance to Clinical Development, CMC, Pharmacovigilance, Medical, and Commercial teams.

• Lead full-cycle NDA/BLA submissions, including dossier preparation, cross-functional coordination, responses to health authority inquiries, RTQ management, and inspection readiness activities.

• Serve as the primary regulatory liaison with CDE/NMPA and other Chinese health authorities during pre-IND, pre-NDA, milestone meetings, and ongoing communications.

• Ensure timely submissions of clinical trial applications, amendments, annual reports, and regulatory documents to support continuous clinical development.

• Oversee development of regulatory briefing packages, meeting request materials, Q&A responses, and risk–benefit assessments.

• Monitor evolving regulatory policies, guidelines, and industry trends in China; integrate updates into regulatory planning and contribute to shaping regulatory frameworks through proactive engagement.

• Provide regulatory oversight for promotional material reviews and lifecycle management to ensure compliance with labeling and advertising standards.

• Represent Regulatory Affairs on cross-functional brand teams, governance committees, and launch readiness groups.

• Mentor and support junior regulatory professionals, fostering a culture of regulatory excellence and operational efficiency.

• Analyze competitor landscapes and regulatory trends to inform strategic decision-making.

• Collaborate closely with global stakeholders such as GRL, GDL, and PSL to maintain alignment between global strategies and China-specific plans.

Qualifications and Experience Required

• Bachelor’s degree in Pharmacy, Life Sciences, Medicine, or a related discipline; Master’s or PhD preferred.

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

• Proven success in leading NDA/BLA submissions and navigating NMPA regulatory processes, including meetings and query responses.

• Strong knowledge of NMPA drug registration regulations, ICH requirements, and global regulatory standards.

• Demonstrated ability to design and execute innovative regulatory strategies in fast-evolving environments.

• Experience leading cross-functional teams with the ability to influence outcomes without direct authority.

• Excellent communication skills in English and Mandarin, with the ability to translate complex regulatory concepts clearly and effectively.

• Strategic, detail-oriented, and results-driven professional with strong analytical and problem-solving capabilities.

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

About Gilead

For more than 35 years, Gilead Sciences has been dedicated to advancing treatments for HIV, viral hepatitis, COVID-19, oncology, and other life-threatening diseases. Each team member contributes to scientific innovation that improves global health. Gilead fosters an inclusive, growth-oriented environment where leaders empower teams to excel and create meaningful impact.