Regulatory Affairs Associate in New Providence, NJ at Apex Life Sciences

Date Posted: 7/19/2018

Job Snapshot

Job Description


Job Summary:

  • Compile, review and submit eCTD submissions to the FDA. 
  • Maintain indices, 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.

Job Responsibilities:

  • Prepare and assist eCTD submissions for generic marketed drug products to ensure timely submissions to the FDA (Supplements (CBE, CBE-30, PAS), and Annual Reports). 
  • Prepare and assist submitting Drug Listing and SPL/PLR submissions
  • Assist and/or manage electronic submissions to FDA in 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
  • 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

Qualification Requirements:

  • Bachelor’s degree in chemistry, biology or other related scientific discipline required.
  • At least 2-3 years in the pharmaceutical industry with at least 1-2 years of Regulatory experience supporting US FDA pharmaceutical products
  • Proficiency in eCTD Publishing Software is a must
  • Excellent attention to details
  • Excellent verbal and written communication skills
  • 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

FOR IMMEDIATE CONSIDERATION please email resume to or call 732-636-1497

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.