Associate Director, Regulatory Affairs

argenx seeks an Associate Director of Regulatory Affairs to lead US regulatory strategy for its pipeline of autoimmune therapies. This role manages pre- and post-approval activities, serves as primary FDA contact, and coordinates regulatory submissions across the product lifecycle in a remote position.

Responsibilities

• Develop and implement US regulatory strategy for assigned projects
• Serve as primary contact and lead FDA interactions, including meeting preparation
• Lead preparation and critical review of IND, BLA, and NDA dossier content
• Ensure timely FDA responses aligned with approved product strategy
• Partner cross-functionally with medical, quality, legal, and distribution teams on regulatory input

Requirements

• Minimum 8 years regulatory affairs experience in biopharmaceutical organizations
• At least 3-5 years in global leadership roles with FDA focus
• PhD or PharmD preferred
• Demonstrated expertise in orphan drug development and FDA submissions
• Experience interacting with regulatory authorities required
• Knowledge of drug development process and evolving global regulatory landscape
• Strong project management, strategic planning, and stakeholder engagement skills

Compensation: $164,000-$225,500 base