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Lilly Regulatory Affairs Manager-China Labeling Coordinator in 北京, China

Job Category:

医学

Type of Employment:

全职员工

Responsibilities:

  • Responsible for any new products artwork development.

  • When the artwork designer is noted to develop the artwork for new product, the artwork designer should be contact the pack site for the artwork template, base on the template and align with China regulation as well as marketing's perspective, then to develop the new artwork. While it is developed, the artwork must be provided to pack site and marketing for their review and approval. Collaborate both comments for the future revision or approval.

  • In-Line products artwork updates or any revision.Timely update the current artwork follow by the regulatory filing request, and match the filing timeline.

  • Word version artwork development for the CDE electronic submission.

  • Communicate with pack site and marketing for the artwork development. Query for their comments and acceptance.

  • Coordinate with supply chain and pack site for the supply plan or the switch timeline. In order to avoid of any write off be happened, any artwork revision communication should be advance and timely.

  • Associate to deal with any issue that relate to artwork. Draft the explanation letter or visit the agency for the face to face explanation.

  • Artwork SOP edit and updates.

  • Tracking and pay attention to the related regulation and well knowledged.

  • Train the artwork system to RA and familiar use to it.

  • Proofreading the artwork and feedback any concern related to the LPC to RA.

  • Initiate the meeting about any artwork issue discussion.

  • Ensure compliance with Company regulatory policies, principles & procedures and the local team is aware and trained on these aspects.

  • ALRP delegates with the labeling responsibilities are responsible for below duties:

  • Affiliate product information complies with regional and local regulatory requirements

  • 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

  • The appropriate Quality unit is notified of labeling errors to determine if labeling assessment report should be completed per GQS132-Health Hazard Evaluation (HHE)

Basic Qualificiations:

  • At least with BS.

  • Preferable to experience in labeling development.

  • Good command of English writing, speaking and listening skill.

  • Good command of Computer operation skill.

  • Self-motivated.

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: 52060BR

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