Senior Director of Asset Regulatory Affairs - Remote

Overview

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

In Short

• Key member of the global regulatory leadership team.
• Support growth needed for pipeline expansion.
• Provide strategic regulatory guidance for assigned compounds.
• Ensure timely regulatory filings and approvals.
• Build relationships with health authorities and stakeholders.
• Collaborate with teams for global submission timelines.
• Mentor members of the regulatory community.
• Stay informed of regulatory updates and changes.
• Drive successful product launches and commercialization activities.
• Foster a culture of collaboration and innovation.

Requirements

• Minimum 15 years of regulatory affairs experience.
• 5-7 years in global leadership roles preferred.
• PhD or PharmD preferred.
• Experience with therapeutics for autoimmune conditions.
• Understanding of biologic drugs development.
• Ability to coordinate critical regulatory documents.
• Strong scientific background.
• Excellent communication and presentation skills.
• Proven leadership and team development skills.
• Ability to work in a fast-paced, results-driven environment.

Benefits

• Inclusive work environment.
• Opportunities for growth and development.
• Engagement in meaningful work.
• Work with a passionate and innovative team.
• Global presence with diverse locations.