Lilly Jobs

Job Information

Lilly Sr. Regulatory Affairs Manager in 北京,

Job Category:

医学

Type of Employment:

全职员工

Responsibilities:

  • Under the general direction of supervisor, independently perform product registration and other activities.

  • Participate in the development of regulatory affairs strategy and action plan.

  • Compile registration dossier and ensure timely regulatory submission upon internal review and approval

  • Communicate with regulatory agencies/institutes(e.g., CFDA, PFDA, CDE, NIFDC, CPC, Coast Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.

  • Timely/closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed.

Ensure earliest possible registration.

  • Properly maintain all regulatory documentation.

  • Cross Functional

  • Provide regulatory expertise to the new product launch activity if necessary

  • Provide inputs and assistance in the development of study protocol in terms of regulatory requirement

  • Provide expertise from regulatory point of view to ensure market supply import and drug inspection complying with local regulation.

  • Participate in development and review regulatory affairs SOP and other functional system

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

  • Perform ad hoc projects or assignments

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

  • Affiliate product information is consistent in content and emphasis with CDS, CD, local regulations and other reference labels as required locally.

  • Submit Proposed Truth copy for new Affiliate Product Information or label updates to regulatory authorities as required. Submit and implement label within the required time frame.

  • Ensure the accuracy of labeling translations, providing a complete and accurate Truth Package to Printed Packaging Development (PPD) and thorough review of Proof Copy.

  • Obtain internal reviewer and Global Product Team approval (with GoLD) if affiliate product/device information that are not consistent with Core Labeling, using SAIL to initiate the Labeling Change/ Exception Request.

  • Ensure labeling document retention, including the Master Truth Copy.

  • Use Lilly’s databases correctly.

  • After get approval letter, inform China Labeling Coordinator to start labeling artwork update/create procedure.

Basic Qualificiations:

  • At least bachelor degree in pharmaceutical or chemical/biopharmaceutical sciences.

  • At least 4-year experience in drug regulatory affairs in globe leading pharmaceutical company.

  • Good leadership and project management skills.

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

  • Good team player.

  • 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: 中国

Location Details:

Req Id: 45581BR

DirectEmployers