Dianthus Therapeutics

The Executive Director, CMC Quality Assurance will lead and build a QA team to support the development, manufacturing, and regulatory approval of all Dianthus products. Reporting to the VP, Head of Quality, the role involves executing and overseeing QA processes that assure global GMP and GLP compliance to Dianthus clinical studies. This is a unique opportunity to join a growing organization and impact combination product development and future pipeline projects.

The Senior Director of Regulatory Affairs will develop and execute global regulatory strategies in collaboration with key stakeholders, serving as the global regulatory lead for the multifocal motor neuropathy (MMN) program and supporting other programs as needed. You will provide expert guidance to cross-functional teams, driving global regulatory submissions, acting as primary liaison with Health Authorities, and interpreting applicable Health Authority regulations and guidance documents to ensure compliance.