Director, Regulatory & Compliance

📋 Description

• Build, implement, and maintain the ethics and compliance program, including policies, training
• Develop and execute regulatory strategies across the product development and commercial lifecycle
• Serve as the primary subject matter expert and liaison for regulatory agency interactions
• Monitor changes in regulatory and legislative requirements, including AI/ML guidance, data privacy
• Lead internal investigations, audits, corrective actions, and remediation activities related to
• Develop and maintain a GDPR-ready data governance framework, including Data Protection Impact

🎯 Requirements

• 14+ years of experience spanning regulatory affairs and/or compliance within biotechnology
• Hands-on experience with FDA submissions and regulatory agency interactions; international
• Demonstrated ability to build or significantly scale regulatory and compliance programs rather than
• Strong understanding of regulatory strategy, ethics and compliance, privacy governance, and
• Experience developing policies, training programs, monitoring processes, reporting mechanisms, and
• Working knowledge of GDPR requirements, including DPIAs, ROPAs, data subject rights

🎁 Benefits

• $195,000–$240,000 base salary.
• Equity opportunities.
• Annual bonus potential.
• Medical, dental, and vision insurance.
• Unlimited vacation.
• Parental leave.