Director, Regulatory CMC Device Leader
argenxGhent, East Flanders, Belgium
Posted March 19, 2026
Full Time
About the Company
argenx is a biotech company that is transforming immunology and delivering medicines that help autoimmune patients get their lives back.
Job Description
Join argenx as Director, Regulatory CMC Device Leader to lead the Regulatory CMC strategies for Device & Combination Drug Products. Lead the global regulatory CMC strategy for combination products throughout their lifecycle, including early development, registration, post-marketing and compliance management.
Requirements
- Deep expertise in global combination product regulations, including FDA (21 CFR Part 4), EMA (MDR/IVDR), and applicable ISO standards.
- Extensive experience leading combination product strategies and submissions from development through post-approval.
- Solid understanding of drug and device development processes, including design control, risk management, human factor studies, and GMP/QMS interfaces.
