- Support the development and implementation of global clinical regulatory strategies, including early- and mid-stage clinical development plans.
- Contribute to the preparation, review, and submission of regulatory documents such as INDs, CTAs, protocol amendments, and marketing applications.
- Partner with clinical development, clinical operations, medical writing, pharmacovigilance, and CMC teams to ensure high-quality regulatory deliverables.
- Plan and prepare for health authority meetings with the FDA, EMA, and other national competent authorities.
- Provide regulatory input into clinical study designs, protocols, investigator brochures, and safety reports.
- Monitor regulatory requirements and guidance documents relevant to oncology, cell therapy, and gene therapy.
- Support cross-functional teams by identifying regulatory risks and proposing mitigation strategies.
GCP