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Breckenridge Pharmaceutical, Inc. considers all qualified applicants for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, disability or status as a protected veteran or any other characteristic protected by law.

All positions are in the Berlin, CT office unless otherwise noted in the job description

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.

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