Manager, Regulatory Affairs (Gene Therapy)

About the role

The Manager, Regulatory Affairs, will play a hands-on, execution-focused role supporting clinical regulatory strategy for ETX-301 in neuropathic pain and contributing to ex-US efforts for ETX-101. This individual will drive day-to-day regulatory activities for clinical-stage gene therapy programs, including preparation and coordination of US and EU submissions and support for global health authority interactions. The ideal candidate brings industry experience in cell and/or gene therapy, a strong foundation in clinical regulatory strategy (vs. purely CMC), and preferably exposure to European regulatory pathways, adult neurology, pain, and/or device or in vitro diagnostic interfaces. This is a US-based remote role (West Coast preferred but not required) reporting into the regulatory leadership team and working cross-functionally in a fast-paced, growing biotech environment.

Responsibilities

• Drive day-to-day execution of regulatory activities for ETX-301 and supporting work on ETX-101 and other gene therapy programs
• Contribute to clinical regulatory strategy, particularly for adult neuropathic pain and CNS-targeted gene therapy
• Prepare, review, and coordinate regulatory submissions (e.g., IND/IMPD amendments, briefing packages, responses to health authority questions)
• Support interactions with US and ex-US health authorities (e.g., FDA, EMA and relevant national agencies), including meeting materials and follow-up
• Partner closely with Clinical Development, Clinical Operations, CMC, Quality, and other cross-functional teams to ensure regulatory requirements and timelines are integrated into program plans
• Monitor, interpret, and communicate relevant global regulatory guidelines and expectations in gene therapy and neurology/pain
• Contribute to risk identification, mitigation planning, and issue resolution from a regulatory perspective
• Ensure high-quality, consistent messaging and documentation across regulatory submissions and internal stakeholders
• Maintain accurate tracking, documentation, and archival of regulatory submissions and correspondence

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 and a Master's degree; or a PhD with 3 years' experience; or equivalent experience.
• Strong understanding of FDA and global regulatory requirements for biologics or gene therapy products
• Solid working knowledge of drug development processes, eCTD standards, and GXP/ICH requirements
• Hands-on experience preparing and maintaining routine IND/CTA filings and safety reporting outputs
• Experience in rare disease, cell therapy, or gene therapy is highly preferred
• Strong organizational, project management, technical writing and communication skills

Skills

• Experience specifically focused on AAV gene therapy or rare diseases
• Direct experience interacting with cross-functional teams, CROs, and regulatory vendors
• Familiarity with expedited regulatory pathways (e.g., RMAT, Breakthrough Therapy, Orphan Drug designations)

Pay

For candidates based in the SFBA area, the salary range for this position is 156,000 - 177,000. For candidates based outside the SFBA area, the salary range is