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Regulatory Affairs Manager - China  

Lilly (company)

Posted on : 01 May 2017

Project Description

Regulatory Affairs Manager
  • Under the general direction of supervisor, independently perform product registration and other activities.
  • Participate in the development of regulatory affairsstrategy and action plan.
  • Compile registration dossier and ensure timelyregulatory 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, CDL, local regulations and other reference labels as required locally.
  • Conduct appropriate review and approval processes, ensure that Affiliate Product Information is accurate and consistent with current medical practices.
  • 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.
  • 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.