(Sr.) Manager-Regulatory Affairs (Compliance & Innovation), China

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Purpose

The purpose of the Manager/Senior Manager, Regulatory Affairs (Compliance & Innovation), China, is to ensure robust compliance with applicable laws, regulations, and internal standards, while proactively supporting regulatory innovation initiatives in China or globally.

The Manager / Senior Manager is responsible for supporting and strengthening regulatory compliance governance in China, including the implementation and execution of local regulatory compliance requirements under relevant Chinese regulations and NMPA expectations. Working in close collaboration with China Regulatory Affairs leadership and key internal partners, this role helps ensure that regulatory activities are conducted in a compliant, consistent, and inspection‑ready manner.

In addition, the Manager / Senior Manager plays an active role in regulatory AI capability building and continuous improvement. The role contributes to embedding a strong culture of compliance and innovation by driving process optimization, sharing regulatory best practices, and supporting effective change management.

The Manager / Senior Manager is expected to actively engage in functional and cross‑functional forums, contribute to regulatory and business discussions, and support the operational effectiveness of the China Regulatory Affairs organization.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

• Regulatory Compliance
• Provide regulatory compliance governance and operational oversight for China Regulatory Affairs, including documentation tracking, recording, archiving, and lifecycle management of licenses, approval letters, labeling, annexes, withdrawal letters, and related regulatory documents.
• Ensure timely, consistent, and flawless implementation of company SOPs, WIs, and compliance requirements in daily regulatory activities.
• Lead and coordinate China local regulatory process development, including SOP/WI drafting, updates, and deployment in alignment with global standards and local requirements.
• Act as the key owner and subject‑matter expert for RA systems, providing operational guidance to ensure timely, high‑quality execution and full compliance with SOPs and regulatory expectations.
• Partner closely with China RA teams to monitor system readiness, identify gaps, and drive continuous improvement of system performance and usability.
• Quality Assurance & Inspection Readiness
• Implement Quality Control and Quality Assurance practices within Regulatory Affairs to ensure the quality, integrity, and compliance of regulatory submissions and regulatory operations.
• Support internal and external compliance monitoring activities and audits, including preparation, execution, issue tracking, and follow‑up actions.
• Maintain inspection readiness through proactive risk identification, documentation control, and continuous process improvement.
• Design and deliver onboarding and role‑based training for new hires, including regulatory compliance, systems, and process training for the China RA team.
• Own China RA shared drive governance, ensuring structured document management, controlled access, and periodic Confidential Commercial Information (CCI) reviews.
• Oversee sample archiving management, including temperature monitoring and compliance with applicable quality and regulatory requirements.
• Manage Third‑Party Organization (TPO) engagement related to regulatory compliance and systems support.
• Digital Enablement & Innovation Support
• Act as a key driver for regulatory digital transformation in China, working in close collaboration with China RA teams, global stakeholders, and external vendors to identify, introduce, implement, and continuously optimize regulatory systems, digital solutions, and AI‑enabled tools in alignment with global strategy and local needs.
• Translate global digital and innovation initiatives into practical China implementation, ensuring new systems and tools are fit‑for‑purpose, compliant with local regulatory and quality requirements, and effectively embedded into China RA processes.
• Lead change management and adoption efforts by engaging stakeholders early, providing clear governance and communication, and supporting training and capability building to ensure sustainable use of new systems and tools.

Working support with other R eg excellence team members

• As a back-up person for China Labeling Coordinator: Get proper knowledge and skill of China Labelling Coordinator, as a back-up person in case China Labeling Coordinator is absent. Support China Labelling Coordinator to conduct internal check on Labelling related activities. •

Minimum Qualification Requirements

• At least bachelor’s degree in Biz Admin, English or Medical/Pharmaceutical related major, at least 3 year’s related working experience.
• Good command of AI/digital skill (i.e. Copilot, Power BI, Smartsheet, coding etc.)
• Self-motivated and Innovative
• Ability to positively impact colleagues and teams
• Very good command of English writing, speaking and listening skill
• Good communication skill

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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