The primary responsibility of this position is to focus on development and execution of regulatory-CMC strategies for gene therapy viral platform programs.

You will lead the regulatory CMC team in planning, writing and reviewing CMC sections for MAAs, BLAs, INDs, CTAs, as well as responses to agencies and briefing documents.

Requirements:

advanced degree preferred.

5 + years’ experience in regulatory CMC and/or viral vector gene therapy technical product development in the biotechnology/biopharma industry

Experience managing CMO/CRO relationships