Manager, Regulatory Affairs

Job Summary

To support clinical regulatory strategy for gene therapy programs, the full-time remote Manager, Regulatory Affairs will manage day-to-day regulatory activities, including preparation and coordination of US and EU submissions and interactions with global health authorities.

Key responsibilities

• Drive execution of regulatory activities for clinical-stage gene therapy programs, including ETX-301 and ETX-101
• Prepare, review, and coordinate regulatory submissions and support interactions with US and ex-US health authorities
• Collaborate with cross-functional teams to integrate regulatory requirements and timelines into program plans

Required qualifications

• Bachelor's or Master's degree in a scientific discipline (Life Sciences, Biotechnology, Biology, or related field)
• A minimum of 8 years of related experience with a bachelor's degree; or 6 years with a Master's degree; or a PhD with 3 years' experience
• Strong understanding of FDA and global regulatory requirements for biologics or gene therapy products
• Hands-on experience with IND/CTA filings and safety reporting outputs
• Experience in rare disease, cell therapy, or gene therapy is highly preferred