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Back To Current Job Listings: Regulatory Affairs Associate
Regulatory Affairs Associate
[Jan 09, 2020]



Under supervision of the Associate Director of Regulatory Affairs, the Regulatory Affairs Associate will assist with document reviews, ANDA eCTD compilation and publishing, labeling creation/ revision and participation in project meetings



  • Create, revise and maintain product labeling including, but not limited to, labels, outserts, cartons, and medication guides per FDA regulations/guidance’s 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 Submission Manager.


  • Update and Maintain databases of important regulatory information including DMF Letters of Authorization, cGMP statements, debarment statements. 


  • Participate in Omnicia updates, as needed.





  • Experience with eCTD software preferred, MSWord, Excel, Adobe Acrobat and other document processing software.


  •  BS required (preferably in a science –Biology, Chemistry or Pharmacy); graduate degree a plus.


Pharmaceutical experience in regulatory, quality or product development operations required.

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