Director, Regulatory Affairs US Lead

Director-level regulatory affairs leadership position accountable for developing and executing US regulatory strategies for rare disease products. Reports to Senior Director of Global Regulatory Strategy and serves as primary FDA point contact for assigned programs.

Responsibilities

• Serve as US strategy lead and submission team lead for assigned regulatory programs
• Lead and manage FDA meetings as primary company contact; coordinate briefing package development
• Develop and direct regulatory strategies; collaborate across clinical, commercial, manufacturing and other functions
• Monitor emerging regulatory requirements and guidance; advise product teams on business impact
• Ensure ethical behavior, transparency and sound risk assessment practices within organization

Requirements

• 8+ years pharmaceutical regulatory affairs experience with US regional strategy focus
• Bachelor's degree in life science; Master's or PharmD/PhD preferred
• Strong knowledge of drug development lifecycle and regulatory environment across multiple jurisdictions
• Demonstrated ability to manage complex, multi-project portfolios simultaneously
• Experience with regulatory documentation systems such as Veeva
• Advanced proficiency with Microsoft Office, particularly PowerPoint
• Excellent written, verbal communication and presentation skills in corporate environment

Compensation: $186,232.80 - $279,349.20 base annual