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Lilly Assoc. Regulatory Affairs Director in 北京, China

Job Category:

医学

Type of Employment:

全职员工

Responsibilities:

  • 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.

  1. 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)

    1. 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

Basic Qualificiations:

  • 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.

Additional Skills/Preferences:

Additional Information:

Company Overview:

Posted Date:

Keyword:

Region: 亚洲/太平洋地区

City: 北京

State: 北京市

Country: CHN

Location Details:

Req Id: 50029BR

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