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

 

For more information on these career opportunities, please e-mail jobs@bpirx.com

 

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

JOB SUMMARY:

 

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

 

DUTIES AND RESPONSIBILITIES: 

  • 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.

 

 

ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE

 

  • 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.

Home  | About Breckenridge  | Products  | Featured Products  | Contact Us  | News  | Careers  | Login
© 2020 Breckenridge Pharmaceutical, Inc.   Powered By: