Na Song

Lead regulatory strategy and operations for global submissions (e.g.,BLA/ IND/CTA, amendments, orphan designations, expedited pathways). Provide expert guidance on clinical development, regulatory standards, and ICH/GCP/GMP compliance. Manage and mentor Regulatory Managers; oversee resource allocation and performance. Represent Regulatory Affairs in cross-functional and client-facing meetings. Ensure regulatory documentation meets quality and compliance standards. Support audits, policy development, and implementation of regulatory tools. Maintain expertise in international regulations and assess emerging requirements. Contribute to business development through proposal generation and strategic input.