Description de l'annonce:

We are looking for a 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

Experience

Should have Computer certification or should have had few months min experience in RA or Publishing