Manager, Regulatory Affairs – Gene Therapy
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Job Description
Regulatory Affairs Manager driving US/EU submissions and health-authority interactions for Encoded Therapeutics’ clinical-stage gene therapy programs. Supporting ETX-301 neuropathic pain and ETX-101 regulatory strategy.
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 for adult neuropathic pain and CNS-targeted gene therapy
- Prepare, review, and coordinate regulatory submissions, including IND/IMPD amendments, briefing packages, and responses to health authority questions
- Support interactions with US and ex-US health authorities, including FDA, EMA, and relevant national agencies
- Partner with Clinical Development, Clinical Operations, CMC, Quality, and other cross-functional teams
- Monitor, interpret, and communicate global regulatory guidelines and expectations in gene therapy and neurology/pain
- Contribute to regulatory risk identification, mitigation planning, and issue resolution
- Ensure consistent messaging and documentation across regulatory submissions and internal stakeholders
- Maintain accurate tracking, documentation, and archival of regulatory submissions and correspondence
- Report into the regulatory leadership team
Requirements:
- 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
- Experience specifically focused on AAV gene therapy or rare diseases is preferred
- Direct experience interacting with cross-functional teams, CROs, and regulatory vendors
- Familiarity with 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 time and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- STD, LTD, Life and AD&D
- Professional development opportunities
- Team-building events
- Fully stocked micro-kitchen
- Fitness center at South San Francisco location
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
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