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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Provide regulatory expertise to propose China registration strategy through working closely with China and global study team and get alignment. Implement, review and update regulatory strategy when necessary. Ensure product registration related activities under Lilly's policies and standard operating procedures, and other applicable laws and regulations. Oversee the progress and ensure product registration approval.
  • Review product registration strategy and action plan. Timely make recommendations to adjust the strategy to related functions and communicate with GRA (Global Regulatory Affairs) and China internal departments for the major changes and rationale.
  • Review and sign registration dossier and other regulatory documents to ensure the data presented fully represent what is practically required.
  • Timely communicate with regulatory authorities to get regulatory feedback.
  • Timely review and communicate registration progress and issues with related functions; provide direction, guidance, and support as needed in analysis and/or solution of the issues.


Cross-functional collaboration
  • Provide input and advice on the new product launch plan in terms of regulatory requirement.
  • Collaborate with related functions to ensure market supply, artwork and labeling comply with agency requirement.


Provide supervision on dedicated TA team, engage, retain and grow junior RA colleagues (when applicable). Participate in development and review of RA SOP and other RA functional system. Ensure compliance with company policies, principles & procedures which China local team is trained on these aspects. Perform the function of delegate ALRP role:
  • Product Information should comply with local reg requirements, and the updated Product Information should be submitted, approved and implemented within the designated internal and/or MOH timelines.
  • Follow global labelling procedures, and document relevant exceptions in order to produce accurate and high-quality Product Information which is in compliance with global core labeling.
  • Perform ad hoc projects or assignments.


Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

#WeAreLilly

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Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
We were founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that meet real needs. More than a century later, we are passionate about building on this precedent in our continued pursuit to make life better for individuals, communities, and the world around us.
Our heritage and our values are the foundation of our promise to unite caring with discovery to make life better for people around the world.
Our mission 
We make medicines that help people live longer, healthier, more active lives.
Our values
Integrity, excellence, respect for people
Our vision 
We will make a significant contribution to humanity by improving global health in the 21st century.

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