- Support the development and implementation of regulatory strategies for assigned studies.
- Create and maintain submission plans, country-level timelines, and document requirements for global study start-up.
- Coordinate the preparation and review of clinical documents including protocols, amendments, informed consent, and briefing documents.
- Prepare, compile, and coordinate clinical trial applications and submissions to global health authorities like FDA and EMA.
- Manage regulatory activities performed by CROs and vendors, ensuring quality and adherence to timelines.
- Support health authority interactions by coordinating cross-functional input and managing response development.
- Anticipate regulatory risks and bottlenecks, providing mitigation strategies to leadership.
Project Management