Manager, Regulatory Affairs (Gene Therapy)

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. For more information, please visit www.Encoded.com.

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.

• 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.
  
  
• Preferred Qualifications
• 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).

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 142,000 - 164,000

Encoded considers a variety of factors when determining base compensation, including experience, qualifications, internal equity and geographic location. Actual compensation will be determined based on relevant skills, experience, qualifications, internal equity, and business needs. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package.