Remote Director of Regulatory Affairs (US)

argenx SE; United States; Hybride; USD 212 000 - 292 000; Plein temps

Avantages offerts par ce poste

Comprehensive benefits package

Incentive programs

Retirement savings plans

Résumé du poste

argënx SE is seeking a Director of Regulatory Affairs to lead the US regulatory strategy and act as the primary liaison with the FDA. The role covers pre- and post-approval activities across a growing pipeline, including INDs and BLAs/NDAs, with collaboration across medical, quality, and distribution functions.

You will drive regulatory submissions, monitor changes in the US landscape, and mentor a team in a fast-paced matrix environment. Remote work option in the United States is available.

Qualifications

• Minimum 10 years in regulatory affairs within biopharmaceuticals.
• At least 5–7 years in global leadership roles focused on FDA.
• Experience with orphan drugs and drug development processes.

Responsabilités

• Develop US regulatory strategy for assigned projects.
• Lead FDA interactions and prepare briefing packages and responses.
• Oversee dossier content for INDs, BLAs, and NDAs.
• Coordinate regulatory documents with clinical, quality, PV, and distribution teams.
• Mentor and manage regulatory staff; drive timelines and deliverables.

Connaissances

FDA interactions

Regulatory strategy

Leadership

Dossier preparation

Clinical / nonclinical knowledge

Formation

PhD or PharmD preferred

Outils

INDs/BLAs/NDAs

Description du poste

argënx SE is seeking a Director of Regulatory Affairs to lead the US regulatory strategy and act as the primary liaison with the FDA. The role covers pre- and post-approval activities across a growing pipeline, including INDs and BLAs/NDAs, with collaboration across medical, quality, and distribution functions.

You will drive regulatory submissions, monitor changes in the US landscape, and mentor a team in a fast-paced matrix environment. Remote work option in the United States is available.