Responsible for the CMC section of RA submissions including NDA, MAA, BLA, IND’s.

Expertise is determined by limited FDA reviews and FDA/Regulatory inquires.

Resolve CMC issues, comply with regulations and recommend regulatory direction to achieve corporate goals.

Create, review and approve internal procedures to ensure CMC submissions meet company requirements of excellence while complying with regulatory requirements and timelines.

Responsible for FDA interactions, strategic RA process and FDA/Regulatory authority negotiation and Change Control.  Requires small molecule expertise