Job Title: Director China Regulatory Lead

Reports To:
VP, Preclinical strategy & China Clinical Development

Location: Shanghai/Beijing China

About Us:

Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Position Summary:

Structure Therapeutics is seeking an experienced and strategic regulatory affairs leader to serve as Director, Head of China Regulatory Affairs. This role will be responsible for leading all regulatory activities in China, ensuring compliance with NMPA/CDE requirements, and driving effective regulatory strategies to support the development of our pipeline from preclinical through clinical stages.

The successful candidate will oversee day-to-day China RA operations, lead regulatory strategy and execution, manage external regulatory resources, and serve as the primary regulatory interface with CDE. This is a key leadership role requiring deep expertise in China regulatory pathways, strong cross-functional collaboration, and hands-on execution capability.

KEY RESPONSIBILITIES

Regulatory Strategy & Leadership

• Lead and execute China regulatory strategies across preclinical and clinical development programs in alignment with global regulatory plans.
• Provide regulatory leadership and strategic guidance to internal cross-functional teams to support program advancement and key development milestones.
• Lead all regulatory activities to ensure full compliance with NMPA/CDE laws, regulations, guidelines, and current regulatory expectations.
• Monitor, interpret, and proactively communicate China regulatory intelligence, including evolving NMPA/CDE regulations, technical guidelines, and policy trends (e.g., HGRAC and other relevant regulatory reforms), and assess their impact on development programs and regulatory strategy.

CDE Interaction & Regulatory Submissions

• Serve as the primary regulatory contact with CDE and other relevant regulatory authorities in China.
• Lead the planning, preparation, and execution of regulatory interactions, including consultation meetings, pre-IND communications, and formal CDE meetings.
• Oversee the preparation, review, and submission of regulatory dossiers, including INDs and amendments, ensuring accuracy, quality, and regulatory compliance.

Preclinical Regulatory & External Resource Management

• Identify, evaluate, and manage external regulatory resources within China to support regulatory and preclinical activities.
• Lead and guide the preparation of preclinical summary modules for China IND, working closely with internal teams and external vendors to ensure scientific rigor and alignment with CDE expectations.
• Provide regulatory input into preclinical development plans and documentation to support successful IND filings in China.

Operational Excellence & Team Leadership

• Oversee day-to-day China regulatory affairs operations, ensuring timely execution of deliverables and adherence to regulatory timelines.
• Build, mentor, and lead China RA capabilities as needed, fostering a culture of accountability, quality, and collaboration.
• Contribute to the development and optimization of internal regulatory processes, SOPs, and best practices.
• Lead and oversee CDE clinical trial registry activities in China, ensuring accurate, timely, and compliant registration, updates, and maintenance of trial information throughout the study lifecycle.

QUALIFICATIONS:

• Advanced degree in life sciences, pharmacy, medicine, or a related discipline; PhD or MD strongly preferred.
• Minimum of 10–12 years of regulatory affairs experience, with significant hands-on experience in China regulatory submissions and CDE interactions.
• Proven experience leading China regulatory strategies at the Director level or above within biotech and pharmaceutical companies.
• Strong working knowledge of NMPA/CDE regulations, guidelines, and current regulatory trends, particularly in preclinical and early clinical development.
• Demonstrated experience preparing and guiding preclinical summary modules and managing external regulatory and scientific vendors in China.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Fluent in both English and Mandarin (written and spoken).