Lilly Regulatory Affairs Manager- LCDDMAC in Bei Jing-北京, China
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 39,000 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 this role is to closely monitor China regulatory environment and ensure timely provision of intelligence to Lilly China RA and relevant functions. Ensure Regulatory team’s GRP compliance in operation.
Regulatory Intelligence and Shaping Regulatory Environment
Closely monitor and analysis China regulatory environment, ensure timely disseminate intelligence information to RA team members and other relevant functions.
Lead for discussion of draft regulation in commenting process and assist in gathering comments from relevant functions. Compose Lilly’s comments to regulatory authorities and external trade associations.
Fulfil regulatory intelligence requests in support of therapeutic area projects.
Provide regulation support for cross-functional discussion and knowledge sharing.
Join Industry Association regulatory related committees, on behalf of Eli Lilly, advocate for regulatory hot topics trying to influence regulatory environment.
Organize team training on new regulatory environment changes, help deliver more learning resources both in Lilly internal and external.
Support MOU work stream(s) to leverage Lilly expertise to contribute China regulatory evolving.
Maintain and develop CN RA website and information databases and promote the use of the website and database. Qualification/Requirements
At least bachelor’s degree in pharmaceutical or chemical/biopharmaceutical sciences, 2-3 year’s regulatory experience is preferred.
Very good command of English writing, speaking and listening skill
Self-motivated and Innovative
Ability to positively impact colleagues and teams.
Good cross-functional communication skill
Good command of computer operation skill Additional Preferences
Capability of working independently
A fast learner of new things
Being optimistic when dealing with emerged situation and always focus on how we improve
Interpersonal/teamwork skills for effectiveness interactions
Self-management skills with a focus on results for timely and accurate completion of completing deliverables
Demonstrated problem solving ability and attention to details
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