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Senior Regulatory Operations Associate

4 months ago

Berkeley Heights, United States Breckenridge Pharmaceutical Full time

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.


The Senior Associate, Regulatory Operations is responsible for helping to plan, schedule and coordinate regulatory submissions in adherence with technical document standards that are fully compliant with FDA and ICH requirements. They will serve as a system administrator for BPI's US Regulatory electronic document management system and as the primary publisher of US Regulatory submissions. This is a hybrid role based in our Berkeley Heights, New Jersey headquarters.


DUTIES AND RESPONSIBILITIES:


Primary responsibilities of this role include the following:

  • Publishes US Regulatory Submissions to the Food and Drug Administration: NDAs, INDs, ANDAs, Amendments, Supplements, Annual Reports, PADERS, etc. on time in accordance with eCTD submission requirements.
  • Works with the Manager as well as document authors or leads across all disciplines to develop and maintain a comprehensive set of e-submission document templates that are fully compliant with FDA and ICH document requirements.
  • Maintains efficient tracking mechanisms for all regulatory information including the archiving and storage of both electronic and hard copy records.
  • Works on all aspects of document workflows associated with submission authoring, review, compilation and publishing for various submission types.
  • Assists in monitoring and maintains familiarity with evolving and/or new regulatory e-submission requirements and under the direction of the Manager of Regulatory Operations, ensures that all functional disciplines are apprised of the changes and trained accordingly.
  • Helps to author, develop and/or collaborate on SOPs and Work Instructions for the eCTD Publishing and/or Electronic Document Management System.
  • Independently track and manage all correspondence between Breckenridge and government agencies, including phone calls, emails, and relevant documents.
  • Accurately update and maintain trackers, spreadsheets and databases in a timely manner.
  • Meticulously meets corporate and departmental filing objectives with strict adherence to FDA/ICH requirements.
  • Monitors and maintains the highest level of eCTD submission standards.
  • Trains new employees in company submission processes and procedures.
  • Performs other related duties as assigned.


ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE


  • Bachelor’s degree in a scientific discipline.
  • Minimum 5 years’ experience in the Pharmaceutical Industry with 3-4 years’ in drug regulatory affairs operations.
  • Knowledge of eCTD publishing systems and standards, EDMS technology and related publishing tools.
  • Working knowledge of US FDA (OGD/CDER) e-submission requirements.
  • Strong written and verbal communication skills.
  • Computer skills required: Microsoft Word, Adobe Acrobat, Microsoft Office Suite, and eCTD publishing software.