Manager, Regulatory Affairs (Gene Therapy)
About The Position
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. 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.
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.
- Strong organizational, project management, technical writing and communication skills.
Nice To Haves
- Industry experience in cell and/or gene therapy
- Strong foundation in clinical regulatory strategy (vs. purely CMC)
- Exposure to European regulatory pathways
- Exposure to adult neurology, pain, and/or device or in vitro diagnostic interfaces.
- 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).
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
