Senior Director, Regulatory Combination Product - Remote

Overview

Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies for severe autoimmune and inflammatory diseases.

In Short

• Role: Senior Director, Regulatory Combination Product.
• Location: Remote.
• Focus on regulatory compliance for biologics-device combination products.
• Collaborate with device development and quality teams.
• Develop strategies for product development and commercialization.
• Lead interactions with health authorities and notified bodies.
• Experience with APFS or Auto-Injectors preferred.
• Strong communication and strategic skills required.
• Support other Regulatory CMC activities.
• Join a growing organization with an expanding pipeline.

Requirements

• Bachelor’s degree in a scientific/engineering discipline.
• Experience in regulatory roles within pharmaceuticals or biotechnology.
• Knowledge of regulations and standards for combination products.
• Proven track record in late-stage development.
• Understanding of ISO and ASTM standards.
• Familiarity with ICH guidelines and GMP requirements.
• Strong collaboration and influencing skills.

Benefits

• Opportunity to work remotely.
• Be part of a mission-driven organization.
• Engage in innovative product development.
• Collaborate with experienced biotech professionals.
• Contribute to improving patient care.