18 days old

Assoc. Regulatory Affairs Director

北京, Beijing
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Assoc. Regulatory Affairs Director
  1. 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

  1. 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.
3. Labeling
  • 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

  • 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.
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  • Science
Posted: 2019-08-02 Expires: 2019-09-09

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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Assoc. Regulatory Affairs Director

北京, Beijing
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