Manager, Regulatory Affairs – Gene Therapy

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the daily implementation of regulatory activities for ETX-301 while also supporting efforts on ETX-101 and additional gene therapy programs.

• Play a key role in the clinical regulatory strategy for adult neuropathic pain and CNS-targeted gene therapy.

• Prepare, review, and coordinate regulatory submissions, which include IND/IMPD amendments, briefing packages, and replies to inquiries from health authorities.

• Assist in interactions with both US and international health authorities, such as the FDA, EMA, and pertinent national agencies.

• Collaborate with Clinical Development, Clinical Operations, CMC, Quality, and other cross-functional teams.

• Monitor, interpret, and convey global regulatory guidelines and expectations related to gene therapy and neurology/pain.

• Contribute to the identification of regulatory risks, planning for mitigation, and resolving issues.

• Ensure consistent messaging and documentation across regulatory submissions and among internal stakeholders.

• Maintain precise tracking, documentation, and archiving of regulatory submissions and correspondence.

• Report to the regulatory leadership team.

⛳️ Requirements

• A Bachelor's or Master's degree in a scientific field such as Life Sciences, Biotechnology, Biology, or a related discipline.

• At least 8 years of relevant experience with a bachelor's degree; or 6 years with a Master’s degree; or 3 years with a PhD; or equivalent experience.

• Strong comprehension of FDA and global regulatory standards for biologics or gene therapy products.

• Solid knowledge of drug development processes, eCTD standards, and GXP/ICH requirements.

• Practical experience in preparing and maintaining routine IND/CTA filings and safety reporting outputs.

• Experience in rare diseases, cell therapy, or gene therapy is highly desirable.

• Excellent organizational, project management, technical writing, and communication skills.

• Specific experience in AAV gene therapy or rare diseases is preferred.

• Direct experience working with cross-functional teams, CROs, and regulatory vendors.

• Awareness of expedited regulatory pathways (e.g., RMAT, Breakthrough Therapy, Orphan Drug designations).

🏝️ Benefits

• Comprehensive benefits package, including competitive employer premium contributions.

• Meaningful stock option grants.

• PTO, sick leave, and holiday pay.

• Generous Parental Leave program.

• Pre-tax medical and dependent care programs.

• Short-term disability (STD), long-term disability (LTD), Life and AD&D insurance.

• Professional development opportunities.

• Team-building events.

• Fully stocked micro-kitchen.

• Fitness center available at the South San Francisco location.

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives.