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

2. 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.

3. 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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