- Support the planning, compilation, QC, and submission of CMC dossier content for clinical and commercial applications.
- Prepare and adapt submission documents for global regulatory use following eCTD specifications.
- Independently plan and prepare routine clinical trial application amendments and commercial submissions including DSURs and health authority queries.
- Manage submission trackers and maintain logs of regulatory correspondence.
- Facilitate communication with CROs and vendors to ensure timely delivery of IND, CTA, and EU-CTR submissions.
- Support the implementation of regulatory strategy across all development stages from IND through BLA/NDA approval.
Microsoft Office