Senior Director, Global Regulatory Affairs – Biotech Unit

📋 Description

• Develop and advise on global regulatory strategies for oncology programs
• Provide regulatory direction across lifecycle from development to post-approval
• Apply US, China, EU, ICH knowledge to guide programs across regions
• Lead regulatory strategy, risk assessments, issue management, interactions with Health Authorities
• Oversee preparation/submission of regulatory docs for INDs/CTAs/NDAs/BLAs/MAAs
• Review regulatory input on submissions and materials

🎯 Requirements

• Bachelor’s in life sciences/pharmacy/medicine; advanced degree preferred
• 12+ years in biotech/pharma; 5+ years in regulatory leadership
• Broad oncology regulatory affairs and drug development experience
• Experience leading activities across at least two major regions
• Proven FDA interactions for oncology products leading to approvals
• Experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management

🎁 Benefits

• Eligibility for an annual bonus plan
• Equity awards and participate in Employee Stock Purchase Plan
• Medical, dental, and vision insurance
• 401(k) retirement plan
• FSA/HSA benefits
• Paid time off and wellness benefits