Breckenridge Pharmaceutical, Inc.
Infinite Menus, Copyright 2006, OpenCube Inc. All Rights Reserved.


For more information on these career opportunities, please e-mail


Back To Current Job Listings: Associate, Regulatory Affairs
Associate, Regulatory Affairs
[Dec 03, 2018]

TITLE:                                   Associate, Regulatory Affairs


REPORTS TO:                       Manager/Director, Regulatory Affairs

Scientific Affairs

CT Office


TRAVEL:                               N/A




Under supervision of the Manager/Director, Regulatory Affairs, the Regulatory Affairs Associate will assist with document reviews, ANDA eCTD compilation and publishing, labeling creation/ revision and participation in project meetings.  Participate in regulatory activities for both pre-approval and post-approval projects.




  • 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. 


  • 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.


·         Review technical/regulatory/clinical documentation related to ANDAs, or other applications, as assigned, to support original submissions, amendments, supplements and annual reports


  • 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.




  • 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 preferred.
Home  | About Breckenridge  | Products  | Featured Products  | Contact Us  | News  | Careers  | Login
© 2019 Breckenridge Pharmaceutical, Inc.   Powered By: