Associate Director, Regulatory Affairs
argenx · Remote
RegulatoryRemoteFull-time$164k–$226kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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