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Senior Regulatory Affairs Associate

2 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.


JOB SUMMARY:

The Senior Associate, Regulatory Affairs is responsible for supporting applications under pre and post approval conditions. A Senior Associate is expected to have a strong understanding of ANDA requirements and demonstrate that knowledge through interactions with partners and in writing/compiling more complex submissions.


DUTIES AND RESPONSIBILITIES:

  • Support pre-approved applications by compiling and authoring complex amendments and original submissions using BPI templates.
  • Under supervision of Regulatory Management, manage post-approval project submissions, including, but not limited to, site transfers, alternate source submissions, analytical changes, container/closure changes, annuals reports and periodic adverse event reports (when applicable).
  • Evaluate proposed changes to applications versus current available guidance documents and formulate filing strategies.
  • Interact with BPI partners to facilitate documentation review/exchange, advance project activities and attend project team meetings in absence of the Regulatory Project Lead, as needed.
  • Under the direction of Regulatory Affairs management, participate in drug development from early stage development through final formulation, ensuring compliance with principles of Quality-by-Design, cGMP, and FDA rules and regulations
  • Support new product launches by filing PLAIR, providing regulatory guidance and ANDA/Supplement approval status, labeling, and drug listing.
  • Provide guidance to partners regarding content of technical/regulatory/clinical documentation.
  • Proficiency in all tasks outlined for Regulatory Associate.


ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE

  • Experience with eCTD software, MSWord, Excel, Adobe Acrobat and other document processing software.
  • Experience with ANDA writing and compilation
  • BS Required (preferably in a science –Biology, Chemistry or Pharmacy); graduate degree a plus.
  • Minimum 3 years’ experience in pharmaceutical regulatory, quality or product development operations.
  • Familiar with cGMP/cGCP requirements.
  • Required to attend off-hours teleconferences with overseas partners.