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

TITLE:                                   Associate, Regulatory Affairs

 

REPORTS TO:                       Manager/Director, Regulatory Affairs

DEPARTMENT:                   
Scientific Affairs

LOCATION:                       
CT Office

 

TRAVEL:                               N/A

 

JOB SUMMARY:

 

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.

 

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. 

 

  • 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.

 


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 preferred.
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