Lilly Regulatory Affairs Director, Bio-Med 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 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 Director Bio-med is to assist RA Dept Head in regulatory and business planning, develop regulatory strategy for responsible TA products, manager regulatory project. And recruit, supervise, train and develop team members, and contribute to local GRP construction.
The Regulatory Affairs Director Bio-med will be responsible for developing regulatory strategy for Bio-med TA product and managing regulatory projects.
Provide regulatory leadership, expertise & value in strategic planning through working closely with international RA and BU RA teams, and get alignment from TA core team task force to accelerate the submission, approval & launch of responsible TA new pipeline (new molecules, indications & line extensions) to improve patient outcomes in China.
Implement regulatory strategies to accelerate submissions & approvals of new products & meet regulatory milestones through operational excellence.
Ensure product registration and perform regulatory affair activities under Lilly’s policies and standard operating procedures, and other applicable laws and regulations.
Communicate with regulatory agencies/institutes and Lilly internal departments on product registration issues.
Monitor and evaluate the new regulations/guidance, regulatory changes/trends, and communicate with internal stakeholders under the direction of RA Dept Head.
Participate in the construction of GRP in RA team.
Develop people and stabilize the team through strong leadership to make sure continuous support to filling project.
Cross-functionalProvide input and advice on the new product launch plan in terms of regulatory requirement.Collaborate with related functions to ensure market supply sufficient, artwork and labeling comply with agency requirement and marketing promotion needs.
Ensure compliance with Company regulatory policies, principles & procedures and the local team is aware and trained on these aspects;
Supervision on dedicated TA RA team engage, retain and grow junior RA colleagues.
Perform ad hoc projects or assignments.
Perform the function of delegate ALRP role:
As Delegate ALRP and through managing the Team Members, ensuring that Product Information complies with Local reg requirements and that updated Product Information is 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
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