Director of Regulatory Compliance

Job Summary

Seeking a hands-on Director of Regulatory Compliance, the full-time remote leader will build and manage the ethics and compliance program, develop regulatory strategies, and serve as the primary liaison for regulatory agency interactions in a dynamic biotech environment.

Key responsibilities

• Build and maintain the company's ethics and compliance program, ensuring alignment with regulatory expectations and best practices
• Develop and execute regulatory strategies across product development and commercial lifecycle, focusing on FDA and international authorities
• Monitor regulatory changes and lead internal investigations, audits, and compliance reporting to ensure organizational adherence

Required qualifications

• 14+ years of experience in regulatory affairs and/or compliance within biotech, pharma, or a related industry
• Hands-on experience with FDA submissions and agency interactions
• Proven ability to build or significantly scale a compliance program
• Bachelor's degree in a scientific or legal discipline; advanced degree (JD, MS, PharmD) preferred
• Strong communication skills to convey regulatory complexities to non-specialist stakeholders