A BDN client is looking for a Regulatory Project Manager to help prepare for the launch of 2 new NDA's. The client is in need of someone who can take the reigns and own an NDA submission. This individual will manage the submission tracker and be able to effectively communicate timelines back to the executive team. This Project Manager (PM) will escalate issues, risks and project change requests to ensure on-time project delivery. He/she will also manage vendor relationships. This PM will need to be an independent worker who can operate under strict timelines. The client is looking for candidates with NDA and Regulatory experience from a Biotechnology/Pharmaceutical background. 6+ years of experience in Project Management is needed. An advanced degree along with Microsoft Project experience is a plus. Oncology product experience also desired.