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Back To Current Job Listings: Senior Project Coordinator, Regulatory Affairs
Senior Project Coordinator, Regulatory Affairs
[Dec 03, 2018]

TITLE:                                   Sr. Project Coordinator, Regulatory Affairs


DIRECT REPORTS:            No


REPORTS TO:                       Manager/Director Regulatory Affairs

Scientific Affairs

Berlin, CT


TRAVEL:                              [10-15%]



Under supervision of the Manager/Director, Regulatory Affairs, the Senior Project Coordinator – Regulatory Affairs will coordinate cross-functional project teams, including internal and external, to drive development; establish project plans with milestones and deliverables.  The Senior Project Coordinator – Regulatory Affairs will support the Regulatory Affairs department by managing department metrics, compile and publish ANDAs in eCTD format, and create and revise labeling,




·         Coordinates with manufacturing partner, development partner and Breckenridge to ensure timely launch of new products to the US market.


·         Coordinates all aspects of the development relationship between the partner and the organization to ensure the timely achievement of milestones in accordance with the applicable agreement.


  • Coordinates project team meetings, prepares meeting agendas and minutes as well as diligently follows up on all action items.


  • Actively manages issues and risks to allow the projects to move forward.  Develops alternative scenarios, with the project team, to address deviations to the plan.


·         Monitors, record and report progress of project activities and milestones.  Tracks, monitors and reports project timelines against established baseline milestones.

  • Independently compile and publish ANDAs in eCTD format in preparation for transmittal through FDA gateway by the Manager/Director.   Compilation includes creating eCTD backbone and performing document preparation through hyperlinks and bookmarks.


  • 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. 


  • Maintain project-related content on Wrike, and manage core team lists.




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


  • Project Management Certification (PMP, PgMP or CAPM) is preferred.


  • Must possess excellent verbal and written skills.


  • Proficient understanding of Project Management Software (Gantt), MSWord, Excel, Adobe Acrobat


  • Minimum 3 years of experience in project management experience, with at least 1 year in the pharmaceutical industry.
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