Regulatory Publisher 588

We are looking for an Regulatory Publisher to develop new challenging projects which would include the following responsibilities:

  • Manage and prepare IND, NDA, BLA, and DMF regulatory applications in eCTD format for submission to the applicable regulatory authority (FDA/HC) in compliance with required timelines and specifications.
  • Perform quality control procedures to ensure completion, correctness, navigability, and adherence to regulatory eCTD guidelines.
  • Perform document management tasks and post-submission activities including file transfer, tracking, database updates and archival.
  • Maintain current knowledge of FDA, HC, and ICH requirements for regulatory submissions, and ensure compliance accordingly.
  • Collaborate with global functional areas to ensure submission-related deliverables are met to achieve strategic business goals.

Education

  • Bachelor’s degree in Life Sciences or related field, certificate in Regulatory Affairs is an asset

Experience

  • 3 to 5 years’ experience in Regulatory Operations with experience with electronic submissions, document formatting and eCTD publishing standards

Skills

  • In-depth knowledge of technologies utilized for creation and management of regulatory submissions and publishing softwares such as Insight Publisher, Lorenz Docubridge, eCTD Xpress…
  • Mastery of handling tools such as “ISI Toolbox”, “Adobe Acrobat Pro”, “Liquent Smart Desk”, and other eCTD related softwares
  • Attention to detail and project management skills and ability to work independently
  • Excellent communication and interpersonal skills

Regulatory Publisher 588