Director, Regulatory Affairs

$212k - $291.5k

argenx

argenx seeks a Director of Regulatory Affairs to lead US regulatory strategy for its immunology pipeline, including the approved VYVGART and pipeline candidates. This director-level role drives pre- and post-approval activities, manages FDA interactions, and serves as a key business partner across the product lifecycle.

Responsibilities

Develop and implement US regulatory strategy for assigned development projects
Serve as primary FDA contact and lead preparation of regulatory submissions and briefing packages
Oversee dossier content development for INDs, BLAs, and NDAs with critical compliance review
Partner with medical, legal, quality, and distribution teams to provide timely regulatory guidance
Monitor regulatory landscape changes and competitive labeling precedents in therapeutic area

Requirements

Minimum 10 years regulatory affairs experience in biopharmaceutical industry
At least 5-7 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 and managing cross-functional teams
Knowledge of current regulatory landscape, global guidelines, and industry trends
Strong strategic planning, project management, and communication skills

Compensation: $212,000-$291,500 base

Apply

Vacancy posted 13 days ago

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