- Our client is a well established company in Guangzhou, China. we are looking for a Manager Regulatory Affairs to handle ANDA filing.
DUTIES AND RESPONSIBILITIES:
* Create, revise and maintain product labeling including, but not limited to, labels, outserts, cartons, and medication guides per FDA regulations/guidances and BPI SOPs. Draft labeling includes MSWord and PDF copies, annotated (side-by-side) labeling as well as working with external sources to create draft printer proofs, as required.
* Review technical/regulatory/clinical documentation related to ANDAs, or other applications, as assigned, to support original submissions, amendments, supplements and annual reports.
* Prepare electronic files for inclusion in eCTD submission by creating files using current eCTD Templates and by hyperlinking and bookmarking files per FDA and BPI SOPs.
* Create and populate eCTD backbone in preparation for transmittal through FDA gateway by the Manager/Director.
* Manage the Periodic Report schedule, and complete periodic report compilation for Manager/Director approval and submission as per the required FDA schedule.
* On a quarterly basis, review the BPI website to ensure that all Medication Guides and Patient Information Sheets are available and that all posted Labeling is current.
* Create, revise and maintain product labeling including, but not limited to, labels, outserts, cartons, and medication guides per FDA regulations/guidances and BPI SOPs. Draft labeling includes MSWord and PDF copies, annotated (side-by-side) labeling as well as working with external sources to create draft printer proofs, as required.
* Review technical/regulatory/clinical documentation related to ANDAs, or other applications, as assigned, to support original submissions, amendments, supplements and annual reports.
* Prepare electronic files for inclusion in eCTD submission by creating files using current eCTD Templates and by hyperlinking and bookmarking files per FDA and BPI SOPs.
* Create and populate eCTD backbone in preparation for transmittal through FDA gateway by the Manager/Director.
* Manage the Periodic Report schedule, and complete periodic report compilation for Manager/Director approval and submission as per the required FDA schedule.
* On a quarterly basis, review the BPI website to ensure that all Medication Guides and Patient Information Sheets are available and that all posted Labeling is current.
5+ years experience
S Krishnan
+91 40 40141006
jobs@cucumberconsultants.com
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