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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.
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.