A BDN client is looking for a strong Regulatory CMC Consultant to take over the majority of the day-to-day work activities related to a BLA submission in order to free up internal resources time to devote to regulatory strategy related activities. The work would include reviewing change controls for regulatory impact, preparing regulatory submissions, work on CMC related modules, SOP writing, and other tasks to support the BLA filing. The client is looking for a candidate with significant experience (someone at a manager or senior manager level) who can take ownership of completing tasks with minimal oversight/direction. The work would be part-time (20-30 hours per week) initially, but there is a possibility to increase to fulltime. The consultant would need to be available to come onsite for 2-3 days and the remainder of the work could be performed remotely.