Director of Regulatory Affairs

Job Summary

A company is looking for a Director of Regulatory Affairs - Gene Therapy.

Key Responsibilities:

• Serve as the regulatory representative on cross-functional teams and communicate regulatory strategies
• Lead the preparation and submission of high-quality regulatory dossiers and ensure compliance with regulations
• Monitor the regulatory landscape and provide strategic guidance for product development

Required Qualifications:

• Bachelor's degree in a scientific field; advanced degree preferred
• 10+ years of experience in Regulatory Affairs, with at least 5 years in gene therapy or orphan drug development
• Experience with IND/CTA submissions and global registration applications
• Prior experience leading interactions with Health Authorities
• In-depth knowledge of US/EU/Japan regulations and ICH guidance documents