CMC Regulatory Dossier Management Director

This role provides PSC Regulatory expertise and leadership for biologics and Bioconjugates commercial and development projects. It leads development of high-quality, phase-appropriate regulatory sections and delivers documents to regulatory operations on aligned timelines. Manages submissions to US INDs, ex-US CTAs, BLAs, and ex-US license applications.

Leads development of CMC-related submissions to regulatory authorities, tracking progress from authoring, reviewing, approving, to publishing across countries and studies. Develops responses to health authority questions and documentation requests. Ensures appropriate archiving of source technical documentation.

Works closely with Bio CMC, Regulatory Affairs CMC, Quality Assurance, and cross-functional project teams. Liaises internally to coordinate CMC changes and externally with vendors, partners, and collaborators. Tracks and manages external partner regulatory actions through completion.

Monitors Biologics CMC regulations and guidance for implications to development and commercial activities. Contributes to processes, SOPs, and continuous improvement opportunities. Provides strategic guidance on review committees and people management oversight.