- Serve as the US regulatory lead for assigned gene therapy programs.
- Develop and execute US regulatory strategies, including expedited approval pathways.
- Act as the primary point of contact for interactions with US regulatory authorities.
- Plan, prepare, and review regulatory submissions including ODD, IND, and BLA applications.
- Coordinate cross-functional teams for FDA meetings and manage briefing document preparation.
- Monitor US regulatory intelligence and implement updates to internal development programs.
- Contribute to regulatory process improvements, SOP development, and audit preparation.
Project Management