Job Opportunities

Publisher – Regulatory Affairs

NDA Group’s US office in Lawrenceville, NJ, is looking for a highly motivated professional to serve as a Regulatory Operations Specialist. This position is responsible for global regulatory submission / dossier publishing, with emphasis on US submissions through eCTD, and will work with a team of Publishers located globally.

Responsibilities include:

  • Preparing document to produce eCTD compliant documents
  • Compiling, publishing and validating electronic submissions in accordance with relevant requirements
  • Electronic lifecycle management (LCM) of submitted NDAs/BLAs
  • Compiling and publishing INDs, NDAs/BLAs and amendments and supplements as well as lifecycle management (LCM)  regulatory submissions
  • Assisting with preparation of NDA-Module 1
  • Contacting clients to assist /discuss a submission
  • Ensuring that the published regulatory submissions are in accordance with the relevant guidelines
  • Producing electronic and paper versions of regulatory submissions with quality control processes
  • Communicating with FDA with respect to electronic regulatory submissions, answering technical queries, and resolving technical issues (with relevant IT support)
  • Monitoring changes and advising clients on ICH and publishing guidelines
  • Set-up and managing dispatches to FDA via the FDA Gateway

Qualifications

We are looking for 5 plus years of experience in regulatory submissions to the FDA including compilation of STFs, CRFs and Datasets. This includes expertise in docuBridge or at least one major publishing software application, knowledge of publishing software and tools used throughout the industry and good awareness of regulatory processes for all types of US submissions.

Application
Please submit a cover letter and resume to lisa.huff-morales@ndareg.com  and indicate Publisher in the subject line. No phone calls please.