Director, Regulatory Affairs

📋 Description

• Lead regulatory strategy for clinical and preclinical programs
• Develop global regulatory plans and timelines
• Drive submissions (CTAs, INDs, PINDs, etc.)
• Ensure submission quality and compliance
• Manage health authority interactions (U.S., Europe, etc.)
• Collaborate across Clinical, CMC, Quality, Medical, and PM

🎯 Requirements

• Bachelors in scientific/engineering/medical field; advanced degree preferred
• 10+ years in regulatory affairs in pharma/biotech
• Experience with clinical development regulatory strategies
• Experience with PINDs/CTAs/INDs for biologics or advanced therapies
• Strong regulatory writing and global regulatory knowledge (FDA/EMA/MHRA)
• Veeva RIM or similar systems experience; MS Office

🎁 Benefits

• Fully remote position for US-based candidates
• Influence global regulatory strategy for gene therapy programs
• Exposure to US, European, and international authorities
• Strategic leadership opportunities across drug development
• Competitive compensation and benefits
• Collaborative, science-driven environment