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.