Director of Regulatory Affairs - Remote

Overview

This role involves leading global regulatory strategies for a clinical-stage biotech company focused on innovative therapies for autoimmune diseases. The position is remote but may require occasional travel to headquarters.

In Short

• Develop and execute global regulatory strategies.
• Serve as the primary regulatory liaison to the FDA and other health authorities.
• Lead and prepare for agency meetings and key filings.
• Ensure timely and accurate fulfillment of regulatory commitments.
• Maintain inspection readiness for regulatory processes.
• Requires 8+ years in pharma/biotech with 6+ years in regulatory affairs.
• Proven success with IND and agency interactions.
• Preferably have NDA/BLA experience.
• Experience with novel small molecules and global clinical trial regulations.
• Excellent communication and project management skills required.

Requirements

• 8+ years in the pharmaceutical or biotech industry.
• 6+ years in regulatory affairs.
• Experience with IND, NDA, and BLA processes.
• Knowledge of global clinical trial regulations.
• Strong communication skills.
• Proven project management abilities.
• Ability to collaborate cross-functionally.
• Experience with novel small molecules.
• Ability to maintain inspection readiness.
• Experience with annual reports and clinical trial registries.

Benefits

• Competitive compensation package.
• Opportunity to work in an entrepreneurial environment.
• Remote work flexibility.
• Occasional travel to headquarters.
• Chance to contribute to innovative therapies for autoimmune diseases.