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

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

Experience

  • 6 months to 2 years Job
  • should have knowledge of Power Point, Microsoft, Computer related activities.