Lilly Regulatory Affairs Director, Diabetes in 北京, China
Type of Employment:
The purpose of Regulatory Affairs Director Diabetes is to assist RAD 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 Diabetes will be responsible for developing regulatory strategy for Diabetes TA products and devices, managing regulatory projects, and enhancing collaboration with Lilly Suzhou manufacturing site.
Category of Responsibility
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, devices) to improve patient outcomes in China.
Provide regulatory leadership, expertise & value in strategic planning through working closely with Global regulatory CM&C group, Global Quality Lab, Su Zhou Manufacturing Site, Customs Service, Business Unit, Regulatory Endo TA, etc, and get alignment from Su Zhou filling project team task force to accelerate the submission, approval & launch of filling project.
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 (e.g., CDA, PDA, CDE, NIFDC, CPC, Coast Drug Control Institute) 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 RAD.
Participate in the construction of GRP in RA team.
Develop people and stabilize the team through strong leadership to make sure contionous support to filling project.
Provide 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.
ALRP delegates with the labeling responsibilities are responsible for below duties:
Affiliate Product Information is consistent in content and emphasis with CDS, CDL, local regulations and other reference labels as required locally.
Conduct appropriate review and approval processes, ensure that Affiliate Product Information is accurate and consistent with current medical practices.
Submit Proposed Truth Copy for new Affiliate Product Information or label updates to regulatory authorities as required. Submit and implement label within the required time frame.
Ensure the accuracy of labeling translations, providing a complete and accurate Truth Package to Printed Packaging Development (PPD) and thorough review of Proof Copy.
Obtain internal reviewer and Global Product Team approval (with GoLD) if affiliate product/device information that are not consistent with Core Labeling, using SAIL to initiate the Labeling Change / Exception Request.
Ensure labeling document retention, including the Master Truth Copy.
Use Lilly's databases correctly.
After get approval letter, inform China Labeling Coordinator to start labeling artwork update/create procedure.
Standards and Inspection Readiness
Ensures SOPs are well understood across the affiliate(s), leading and providing clarification on local implementation
Supports the development of global SOPs to ensure alignment with local laws and regulations
Quality Control and Planning
Helps to interpret relevant regulations and guidelines and acts as a contact person in the affiliate(s)
Sets up and maintains the quality system at affiliate level to meet regulatory expectation and business need
Minimum Qualification Requirements:
At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences
At least 10-years experience in drug regulatory affairs with at least 5-year supervisor experience in global leading pharmaceutical company
Good command of English writing, speaking and listening skill
Self-motivated and Innovative
Req Id: 56022BR