Global Regulatory Affairs Director — FDA Strategy & Submissions

argenx SE; United States; Remote; USD 212,000 - 292,000; Full time

Job summary

argenx SE is seeking a Director Regulatory Affairs to lead the US regulatory strategy across assigned programs, partnering with the FDA and cross-functional teams to guide pre- and post-approval activities and support product launches.

This role requires 10+ years in regulatory affairs with FDA-focused global leadership, strong dossier experience for INDs, BLAs/NDAs, and strategic input to development documents. The position offers competitive compensation and comprehensive benefits.

Qualifications

• Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations, including global leadership with FDA focus.
• PhD or PharmD preferred.
• Experience in rapidly growing pharmaceutical organizations is desirable.
• Deep understanding of drug development and orphan drugs with global regulatory knowledge.
• Ability to coordinate development of regulatory documents for FDA approval.
• Strong communication with scientists, clinicians and regulators.

Responsibilities

• Develop and implement robust US regulatory strategy for assigned projects.
• Provide strategic, operational and tactical input on pre- and post-approval activities with a US focus.
• Serve as primary contact with the FDA.
• Lead interactions with regulatory authorities and prepare briefing documents and replies.
• Lead dossier content for INDs, BLAs/NDAs and related submissions.
• Ensure timely, compliant responses to FDA questions and align with product strategy.
• Contribute regulatory input to development documents including protocols and reports.
• Collaborate with medical, legal, quality, PV, and distribution teams for timely regulatory input.
• May lead Global Regulatory Lead projects as needed.
• Monitor changes in US regulatory landscape and competitive precedents.

Skills

FDA experience

Regulatory leadership

Orphan drugs

Regulatory strategy

Science affinity

Team leadership

Project management

Cross-functional

Communication

Global regulation

Education

PhD/PharmD preferred

Job description

argenx SE is seeking a Director Regulatory Affairs to lead the US regulatory strategy across assigned programs, partnering with the FDA and cross-functional teams to guide pre- and post-approval activities and support product launches.

This role requires 10+ years in regulatory affairs with FDA-focused global leadership, strong dossier experience for INDs, BLAs/NDAs, and strategic input to development documents. The position offers competitive compensation and comprehensive benefits.