Assoc. Regulatory Affairs Director
礼来中国BeijingUpdate time: May 27,2019
Job Description
- Regulatory Intelligence
- 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
- Regulatory Quality
- 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)
4. Others
- 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
基本资格要求
- 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.
地区
亚洲/太平洋地区
国家
中国
城市
北京
职位过期
2020-05-22
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