Director, Regulatory Affairs

Role: Senior Regulatory Affairs leader responsible for developing and executing US regulatory strategies for argenx's biopharmaceutical portfolio, supporting global product development and commercialization. Responsibilities include serving as primary FDA contact, managing interactions, preparing IND/BLA/NDA dossiers, reviewing submission content for compliance, and providing strategic regulatory input across the product lifecycle. The role also involves monitoring regulatory landscape changes, advising cross-functional teams on regulatory requirements, and potentially leading global regulatory projects. Requirements: minimum 10 years in regulatory affairs within biopharma, with at least 5-7 years in global leadership roles focused on FDA interactions; PhD or PharmD preferred. Expertise in orphan drugs, regulatory policies, and experience with rapidly growing organizations are desired. Skills include strong communication, strategic planning, project management, and ability to collaborate across scientific, clinical, legal, and quality functions. High-value specifics: focus on autoimmune indications, biologics, and early to late-stage development; extensive FDA engagement and dossier submission experience. Work setup and travel details are not specified.