Senior Director, Regulatory Combination Product
Dianthus Therapeutics, Inc.New York, New York, United States • Waltham, Massachusetts, United States
Posted October 3, 2025
Full Time
About the Company
Dianthus Therapeutics is a clinical-stage biotechnology company based in New York City and Waltham, Mass. Focused on developing novel monoclonal antibodies with enhanced selectivity and potency, the company aims to create transformative medicines for severe autoimmune and inflammatory diseases. Led by an experienced team of biotech and pharma executives, Dianthus is pioneering next-generation antibody complement therapeutics.
Job Description
Dianthus Therapeutics is seeking a Senior Director, Regulatory Combination Product to define and drive regulatory compliance for biologics-device combinations. The role involves collaborating with device development, device quality, and CMC Teams to support the development and commercialization of therapeutic products for rare diseases. This is a unique opportunity to join a growing company focused on high-quality antibody therapeutics.
Requirements
- Effective communication skills
- Experience with biologics and combination products
- Strong knowledge of regulations, standards, and guidelines related to combination products
- Experience in late-stage development of combination products
- Solid understanding of regulatory standards and GMP requirements
