Interacts with management and technical personnel at all levels within Research, Development and Regulatory Affairs, as well as with personnel at contract manufacturing and testing sites. Serves as a Project Team member, coordinates, schedules, and tracks all development activities relevant to CMC development internally and at multiple contract sites. The experience required is an education in a scientific discipline with a minimum of 3-5 years experience CMC Regulatory Affairs.
Position requires scientific expertise and drug development skills.
Experience with the preparation of several NDA s required and with inhalation products desired.