Regulatory Affairs Specialist

Job Description

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.

The purpose of Regulatory Affairs Specialist (China Labeling Coordinator) is to perform product artwork related activities.

1. Labelling

• Responsible for any new products artwork development, work together with artwork designer and pack site to prepare artwork. And make sure the artwork to meet China regulation as well as marketing's perspective.
• For artwork updates of post marketed products, timely update the current artwork according to China regulatory requirements.
• Truth Copy/Truth Package is complete and accurate prior to transferring to printed packaging development
• Coordinate with supply chain and pack site for the supply plan and/or the switch timeline. In order to avoid of any write off be happened, any artwork revision communication should be in advance and timely.
• Keep routine contact with pack site and packaging operation to figure out timing for implementation of the updated Affiliate Product Information in packaging operations
• Associate to deal with any issue that related to artwork.
• Centralized manage SAIL/Blue/Regulus system in RA team, closely work with ALRPs and update system timely.
• Tracking and pay attention to the related regulation and well known.
• Proofreading the artwork and feedback any concern related to the LPC to RA.
• Ensure artwork development to comply with Company policies, principles & procedures, and the local RA team has the awareness on these aspects.
• The appropriate Quality unit is notified of labelling errors to determine if labelling assessment report should be completed per GQS132-Health Hazard Evaluation (HHE)

2. Quality

• Artwork SOP maintenance

Minimum Qualification Requirements:

• At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences, regulatory experience is preferred
• Preferable to experience in labeling development.
• Good command of English writing, speaking and listening skill.
• Good command of Computer operation skill.
• Self-motivated.

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 ( [email protected] ) 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.