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

  • 1 year to 10 Years max in RA (Publishing Plus)

Skills

  • In-depth of Regulatory Affairs in EU Region. (Publishing Plus)

Regulatory Publisher (Jr.) 620