Director, Global CMC Regulatory Affairs

Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies, shaping strategies for accelerated development and successful product registrations.

The role partners with CMC, Quality, and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD, ensure regulatory readiness, and oversee changes across regions from development through commercialization.