Lilly Assoc. Regulatory Affairs Director in 北京, China
Type of Employment:
Closely monitor China regulatory environment, and ensure timely delivery of intelligence information to relevant functions
Develop and maintain CN RA website and Regulatory information databases
Support for CN RA management in efforts to influence external environment , and coordinate partnership programs with regulatory agency if assigned
Join Industry Association regulatory related committee(s) , on behalf of Eli Lilly, to influence external environment
Enhance competitive intelligence capacity to support CN RA
Manage the effective Regulatory Quality Systems, including SOPs
Organize regulatory training, including new employee training together with team leaders
Arrange self inspection and coordinate regulatory audit
Management of Archiving procedure and dossiers, including registration dossiers, communication/interaction with regulatory authorities and regulatory approval documents.
Management of CN RA filing room, where stores regulatory related dossiers, approval documents and drug samples for testing.
New product: Provide support on PI content proofreading and labelling design
Post approval labelling change: Upon RAP notification of labelling related change approval, conduct communication with PPD and manufacturing site(s), to garrantee
100% accuracy of labelling content;
One-voice communication of implementation timeline to manufacturing site(s); and
- Labelling related compliance with China regulation.
As Alternative ALRP role, provide support to team on labelling related quality control
Affiliate product information complies with regional and local regulatory requirements
The updated Affiliate Product Information is submitted to regulatory authorities within the designated timeline
GoLD is informed of the date of regulatory submission and date of regulatory acceptance/approval
The appropriate printed packaging development site and packaging operation are identified and notified of the date of regulatory acceptance/approval and designated timing for implementation of the updated Affiliate Product Information in packaging operations
Affiliate Product Information for marketed products is maintained
Truth Copy is kept under version control
Truth Copy/Truth Package is complete and accurate prior to submission to printed packaging development
Agreement with Regulatory Authorities regarding changes to submitted Affiliate Product Information are documented and communicated to GoLD
The appropriate Quality unit is notified of labeling errors to determine if labeling assessment report should be completed per GQS132-Health Hazard Evaluation (HHE)
Develop people and keep talent(s) in each of Intelligence/Quality/Labeling function.
100% Completion of ITP courses timely and comply with Lilly rules and prodecures
Commitment to Protecting Lilly
At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences, regulatory experience is preferred.
Very good command of English writing, speaking and listening skill
Good command of Computer operation skill
Self-motivated and Innovative
Ability to positively impact colleagues and teams.
Req Id: 50029BR