Position Overview:The Senior Regulatory Affairs Associate / Manager (Pre-Approval) will compile, review and submit eCTD submissions to the FDA. The candidate in this role MUST have solid experience with pre-approval activity.


  • Maintain records and processes for all regulatory applications
  • Maintain GDUFA Self-Identification, User Fee and Establishment Registration processes
  • Demonstrate solid teamwork with RA team members; meet aggressive deadlines to ensure that Regulatory Agency receive timely and quality submissions to support Company s goals and objectives
  • The Senior Regulatory Affairs Associate / Manager (Pre-Approval) will prepare and assist submitting eCTD submissions for generic and new drug development projects and marketed products to ensure timely submissions to the FDA (Original Applications, Amendments, Supplements, and Annual Reports)
  • Senior Regulatory Affairs Associate / Manager (Pre-Approval) prepare and assist with submitting Drug Listing and SPL/PLR submissions
  • Assist and/or manage electronic submissions to FDA in the eCTD format
  • Assist in reviewing change control documents, batch records, and other technical documents
  • Coordinate and work with Regulatory/R&D colleagues for the preparation regulatory submissions
  • Maintain and improve working knowledge of current/pending regulations and guidances for generic drugs and new drugs to ensure compliance with Regulatory Agency requirements
  • Participate in the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate consistency
  • Organize and maintain Regulatory application records and indices in the Regulatory Operation Center
  • Senior Regulatory Affairs Associate/Manager (Pre-Approval) will assist in the preparation and review of labeling and promotional materials for submission to the Regulatory Agency
  • Maintain GDUFA Self-Identification status and update annually
  • Assist in annual GDUFA User Fee payments
  • Maintain/update Facility Establishment Registration status
  • Maintain and renew other permits and licenses
  • Assist in authoring and finalizing departmental SOPs
  • Perform all other duties as assigned, or as business needs require


  • The Senior Regulatory Affairs Associate / Manager (Pre-Approval) MUST have at least 5 years in the generic pharmaceutical industry with at least 4 years of regulatory experience supporting US FDA pharmaceutical products
  • MUST have experience with the ANDA submission process from start to completion
  • SPL labeling experience is a plus
  • MUST have pre-approval experience
  • Proficiency in eCTD publishing software is a must
  • Excellent attention to details
  • Excellent verbal and written communication skill
  • Good understanding of regulatory requirements for ANDAs and 505b(2) applications
  • Previous R&D (analytical or formulation) experience is a plus
  • 505b(2) experience is a plus
  • Good knowledge of FDA guidelines, ICH and related guidelines
  • Demonstrates a basic understanding of pharmaceutical drug development.
  • Proficiency in Microsoft Office and XML programs
  • Ability to manage timelines and priorities
  • Ability to work independently with some guidance
  • Ability to multi-task
  • Ability to establish and maintain a good working relationship
  • Pre-approval experience is a MUST
  • Some post-approval experience is desirable

Education Requirements:

  • Bachelor s degree in chemistry, biology or other related scientific discipline required

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