Director, Regulatory & Compliance

📋 Description

• Build and maintain the company's ethics and compliance program, including policies, training
• Develop and execute regulatory strategy across the product development and commercial lifecycle
• Monitor the evolving regulatory and legislative landscape — including updates to AI/ML guidance
• Serve as primary liaison for regulatory agency interactions, submissions, and inspections —
• Lead internal investigations and audits; manage corrective action and remediation processes
• Develop and implement a GDPR-ready data governance framework, including data protection impact

🎯 Requirements

• 14+ years of experience spanning regulatory affairs and/or compliance in biotech or pharma
• Hands-on experience with FDA submissions and agency interactions; international regulatory
• Experience with GDPR compliance, privacy program development, and data protection governance —
• Ability to build or significantly scale a compliance program rather than just maintain one
• Comfortable operating without a large team; a builder and self-starter who thrives in a fast-paced
• Strong communicator who can translate regulatory complexity for non-specialist stakeholders

🎁 Benefits

• Medical, dental, vision insurance
• Unlimited vacation
• Parental leave
• Employee assistance program
• Voluntary life and disability insurance
• Annual bonus potential